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QA Specialist I/Ii, QA Manufacturing-logo
KBI BiopharmaBoulder, CO
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: The Quality Assurance Specialist I/II Manufacturing is responsible for assuring products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations. This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for review and approval of executed procedures, equipment logs, and batch records supporting all aspects of cGMP operations. Position Responsibilities: Perform compliance review on the following executed records: batch and solution record (includes on-the-floor review of records) and associated forms, in-process data, and applicable logs Author new and revised Standard Operating Procedures, Forms/Logs, Master Batch Records and Solution Records Support Manufacturing changeover process Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner Author, review, and approve deviation investigations Support client batch record review process Support QA Raw Material group with release of raw materials as needed Able to react to change productively and handle other essential tasks as assigned. Position Requirements: QA Specialist I: Bachelor's degree and 2 years of experience QA Specialist II: Bachelor's degree and 6 years of experience Experience in a cGMP QA environment or equivalent is preferred. Salary Range: Specialist I: $55,000 - $75,900 Specialist II: $74,000 - $102,300 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com. KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. Please note: Our pre-employment drug screening includes substances that are legal in Colorado but remain illegal under federal law, such as marijuana. A positive result for these substances may result in disqualification from employment consideration. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 2 weeks ago

QA Specialist I/II, QA Manufacturing-logo
KBI BiopharmaBoulder, Colorado
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: The Quality Assurance Specialist I/II Manufacturing is responsible for assuring products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations. This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for review and approval of executed procedures, equipment logs, and batch records supporting all aspects of cGMP operations. Position Responsibilities: Perform compliance review on the following executed records: batch and solution record (includes on-the-floor review of records) and associated forms, in-process data, and applicable logs Author new and revised Standard Operating Procedures, Forms/Logs, Master Batch Records and Solution Records Support Manufacturing changeover process Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner Author, review, and approve deviation investigations Support client batch record review process Support QA Raw Material group with release of raw materials as needed Able to react to change productively and handle other essential tasks as assigned. Position Requirements: QA Specialist I: Bachelor’s degree and 2 years of experience QA Specialist II: Bachelor's degree and 6 years of experience Experience in a cGMP QA environment or equivalent is preferred. Salary Range: Specialist I: $55,000 - $75,900 Specialist II: $74,000 - $ 102,300 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate’s qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com . KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds – regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status – and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. Please note: Our pre-employment drug screening includes substances that are legal in Colorado but remain illegal under federal law, such as marijuana. A positive result for these substances may result in disqualification from employment consideration. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 2 weeks ago

Director - QA Iapi-logo
Eli Lilly and CompanyIndianapolis, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. #WeAreLilly Responsibilities: The Associate Director- Quality Assurance (QA) is responsible for managing the activities of QA personnel supporting the oversight of Insulin or Peptide Purification Active Pharmaceutical Ingredient (API) manufactured within Indianapolis Active Pharmaceutical Ingredient (IAPI) manufacturing site. The Associate Director- QA is primarily responsible for the productivity and development of the QA employees, the quality of the product/results, oversight of manufacturing and support operations and overall customer service. It is expected that the Associate Director will oversee the department's performance, resolution of quality issues, and regulatory compliance. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives. Inspection Readiness focus through developing and maintaining processes that support inspections and audits; prepare individuals to interact with inspectors and auditors. Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency inspections. Conduct performance management and development of QA staff; Partner within QA and across functional disciplines to influence and implement the site continuous improvements, site business plan objectives, and GMP Quality Plan objectives Provide coaching/feedback to and develop QA employees. Utilize Human Resources tools to ensure that the right individuals are in the right job (e.g., Performance Management, Merit Delivery, Talent Assessment, Succession Planning and Staffing). Participate in organizational planning. Provide input into the business plan and ensure conformance to department budget for area of responsibility. Exhibit cross-functional influence. Maintain and improve quality systems. Review and approve deviations, procedures, protocols, and change controls with focus for improving the overall manufacturing and/or business processes Participate in self assessments and regulatory agency inspections. Ensure internal and external quality and supply commitments are met. Provide quality management oversight for API manufacturing, laboratories and warehouses. Investigate complaints. Manage the creation, revision and maintenance of cGMP documents (e.g., job aids, procedures, forms, job descriptions). Provide oversight and review of changes to the Global Quality Standards and ensure local implementation of changes. Network with other sites regarding new or current quality systems. Basic Qualifications: Bachelor's Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or other related field. 5+ years of experience in pharmaceutical manufacturing environment in any of the following associated disciplines: TSMS, Production, Quality Assurance, Quality Control, Engineering, Project Management, Development, Procurement. Additional Skills/Preferences: Experience in Manufacturing, QC, QA, Technical Services, Engineering or Regulatory Affairs. Excellent interpersonal skills and networking skills. Ability to organize and prioritize multiple tasks. Demonstrated strong problem solving and analytical thinking skills with strong attention to detail. Demonstrated understanding of computer applications. Demonstrated strong written and verbal communications skills. Ability to influence and lead diverse groups; communicate and influence effectively across functional groups and stakeholders Understanding of statistical tools and analysis. Previous experience supervising/leading people. Influences complex regulatory, business, or technical issues within the site and function Builds relationships with internal and external customers and partners Demonstrated Project Management skills and ability to coordinate complex projects Strategic thinking and ability to balance short term needs with long term business evolution Enthusiasm for changes, team spirit and flexibility Additional Information: Minimal travel ( Some off-shift work (night/weekend) may be required to support 24/7 operations Tasks require entering manufacturing and laboratory areas which require wearing appropriate PPE. Must carry a work mobile to support 24 hour/day operations. This role is onsite with the ability to work from home four days per month. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $118,500 - $173,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Posted 4 days ago

QA Test Automation Engineer-logo
Morgan StanleyAlpharetta, GA
In the Technology division, we leverage innovation to build the connections and capabilities that power our Firm, enabling our clients and colleagues to redefine markets and shape the future of our communities. This is a QA Engineering III position at Director level, which is part of the job family responsible for devising test strategies, conducting and/or coordinating tests, and identifying defects to maintain high standards of performance and reliability. Morgan Stanley is an industry leader in financial services, known for mobilizing capital to help governments, corporations, institutions, and individuals around the world achieve their financial goals. Interested in joining a team that's eager to create, innovate and make an impact on the world? Read on. As a Test Automation Engineer you will manage QE teams delivering both manual and automated quality testing for financials and securities trading front-end applications. Your understanding of security financial data and securities trading, your experience leading testing of front-end web applications, and your collaborative yet firm approach to getting things done will be critical to your success in this role. This is an individual contributor role requiring hands-on experience in test automation, mobile and API testing along with leadership capabilities to guide and collaborate with offshore teams. What you'll do in the role: Design, develop, and execute manual and automated test cases for web, mobile and API applications Ensure end-to-end quality by implementing testing strategies, automation frameworks, and best practices Work closely with developers, product and business stakeholders to align testing efforts with project requirements Act as a bridge between onshore and offshore QA teams, ensuring smooth coordination, knowledge sharing and timely issue resolution Drive and mentor QA team providing technical guidance and ensuring best QA practices are followed Collaborate in Agile environments, actively participating in sprint planning, stand-ups and retrospectives Continuously improve testing processes, identify gaps and implement automation where feasible. Ensure production roll testing staffing and attend production rolls as needed Coordinate tool enhancement needs with infra/tools team Communicate on team's behalf to both technical and non-technical audiences Work in an agile environment with various scrum teams, using test management tools such as JIRA / XRAY What you'll bring to the role: Bachelor's degree or equivalent combination of technical education and work experience 7+ years of experience in information technology/software development with a proven ability to ensure high quality results and with expertise in test automation, agile methodologies and QA best practices. Strong hands-on experience in Java Selenium for UI automation Demonstrated knowledge of Financials and securities trading instruments offered on Morgan Stanley/E*TRADE Solid knowledge of QA methodologies, test planning, system dependencies, and product integration phases Ability to lead teams in a fast-paced environment with short sprint cycles Exposure to the Atlassian tool sets, Bitbucket, JIRA, Confluence, etc. Experience in mobile testing and API testing using tools like postman, Rest Assured Excellent communication and coordination skills, with the ability to collaborate effectively with onshore and offshore teams Preferred Qualifications: BS or MS degree in Computer Science, Information Systems, or Engineering Experience with Jenkins, Git, BitBucket, Perfecto, SauceLabs cloud, Java, Selenium WHAT YOU CAN EXPECT FROM MORGAN STANLEY: We are committed to maintaining the first-class service and high standard of excellence that have defined Morgan Stanley for over 89 years. Our values - putting clients first, doing the right thing, leading with exceptional ideas, committing to diversity and inclusion, and giving back - aren't just beliefs, they guide the decisions we make every day to do what's best for our clients, communities and more than 80,000 employees in 1,200 offices across 42 countries. At Morgan Stanley, you'll find an opportunity to work alongside the best and the brightest, in an environment where you are supported and empowered. Our teams are relentless collaborators and creative thinkers, fueled by their diverse backgrounds and experiences. We are proud to support our employees and their families at every point along their work-life journey, offering some of the most attractive and comprehensive employee benefits and perks in the industry. There's also ample opportunity to move about the business for those who show passion and grit in their work. Morgan Stanley's goal is to build and maintain a workforce that is diverse in experience and background but uniform in reflecting our standards of integrity and excellence. Consequently, our recruiting efforts reflect our desire to attract and retain the best and brightest from all talent pools. We want to be the first choice for prospective employees. It is the policy of the Firm to ensure equal employment opportunity without discrimination or harassment on the basis of race, color, religion, creed, age, sex, sex stereotype, gender, gender identity or expression, transgender, sexual orientation, national origin, citizenship, disability, marital and civil partnership/union status, pregnancy, veteran or military service status, genetic information, or any other characteristic protected by law. Morgan Stanley is an equal opportunity employer committed to diversifying its workforce (M/F/Disability/Vet).

Posted 1 week ago

M
MiMedx Group Inc.Marietta, GA
At MIMEDX, our purpose starts with helping humans heal. We are driven by discovering and developing regenerative biologics utilizing human placental tissue to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare. Possessing a strong portfolio of industry leading advanced wound care & surgical products, we are committed to making a transformative impact on the lives of patients we serve globally. Will you join us on this journey? We are excited to add Senior QA Product Release Associate to our Quality Assurance team! This role will be a on site. The position will pay between $18.00-28.00 per hour based on previous relevant experience and educational credentials. POSITION SUMMARY: Will review documentation of actual process performed in the manufacture of any/all products to ensure compliance with all standard operating procedures (SOP's) and applicable regulations. Inspect all new products and determine their acceptability for release for distribution/shipment; inspect returned products to make final disposition determination. Work to resolve identified errors and deviations, review and maintain applicable records, and ensure compliance with quality system standards, policies, and procedures. ESSENTIAL DUTIES AND RESPONSIBILITIES: Review documentation records within the CEA completed by technicians during processing of any/all products to ensure proper procedures were followed Identify any errors/deviations in processing records and work with appropriate individual(s) to resolve, and/or submit for review/approval as needed Inspect final products identified as ready for release by packaging technician to determine acceptability for distribution and shipment (e.g. product is in proper packaging, correct label, untampered safety seal, etc.); compare documentation records to visual inspection of product Inspect the condition of all returned products and determine final disposition (e.g. can it be returned to inventory, does it require re-packaging, should it be discarded as waste, etc.) Identify any issues with returned products (e.g. wrong quantity received, opened packaging, etc.; notify management and customer service (who processes returns) Review quality control records to ensure accuracy and acceptability of analytical results including product moisture levels, and out-of-specification investigation documentation, as applicable Make final determination of product availability (new and returned goods) for use; move product both physically and electronically (e.g. inventory database) from packaged goods quarantine room/returned product quarantine to release product storage room Communicate inventory levels related to newly released new product and/or returned products to fulfillment departments (i.e. operations, shipping/storage) Reconciliation of processing records for technician documentation of donor processing Review autoclave logs, equipment maintenance records including environmental monitoring results, and cleaning logs, etc. Manage the transfer of completed, hard copy processing charts and donor records to quality assurance storage areas across different company's facilities; help with inventory activities of all records prior to shipment to off-site storage facilities for record retention and tracking purposes Perform customer validations by verifying product shipping addresses are compliant with regulatory requirements (i.e. being shipped to freestanding healthcare facility); communicate non-compliant issues to customer service Ensure company-wide compliance to quality system standards and procedures; identify, recommend, and assist with the development and implementation of needed improvements PROBLEM SOLVING: Effectively identifies problems as they occur and takes appropriate steps to solve them in situations where the problem is not difficult or complex Refers complex, unusual problems to supervisor DECISION MAKING/SCOPE OF AUTHORITY: Under general supervision, exercises some judgement in accordance with well-defined policies, procedures, techniques Work typically involves regular review of output by a senior coworker or supervisor SPAN OF CONTROL/COMPLEXITY: Fully functioning support role having greater responsibility to perform all (or most) of the standard work within the function; moderate impact to the department EDUCATION/EXPERIENCE: Bachelor's degree in related field or equivalent work experience Specialized skill training; certification may be required Prefer knowledge of AATB, FDA, and other state/federal regulations SKILLS/COMPETENCIES: Excellent oral, written, and interpersonal communication skills Proficient in Microsoft Office (Excel, Word, etc.) Organized, flexible, and able to multi-task while maintaining a high level of efficiency and attention to detail Must show aptitude to develop appropriate skills needed for the job WORK ENVIRONMENT: The work is typically performed in a normal office environment, processing lab or warehouse. Role routinely uses standard office equipment; may require use of lab equipment (i.e. refrigerator). Will be required to comply with proper protective equipment guidelines (e.g. gloves, masks, lab coats, etc.), as applicable.

Posted 30+ days ago

C
CSL GlobalEMEA, DE
Für die Abteilung Qualitätssicherung CSL Plasma in Göttingen suchen wir ab sofort einenMitarbeiter (m/w) im Qualitätsmanagement zur Ausbildung zum GxP-Auditor mit sehr guten Sprachkenntnissen in Deutsch, Italienisch, Französisch oder Spanisch (verhandlungssicher) (Vollzeit / befristet)Ihre Tätigkeiten: Unterstützung der Teamleitung in der Betreuung und Qualifizierung von Plasmalieferanten / Dienstleistern im Europäischen Raum Vorbereitung der Audits inklusive Reiseorganisation Durchführung von Qualifizierungsaudits bei Plasmalieferanten / Dienstleistern nach GxP im Europäischen Raum, Überprüfung der Compliance im Hinblick auf regulatorische und gesetzliche Vorgaben Evaluierung der Auditergebnisse, Durchführung von Risikoanalysen und Bewertung der Auswirkungen auf den Qualifizierungsstatus des Plasmalieferanten / Dienstleisters; Bewertung der korrektiven / präventiven MaßnahmenIhr Profil: Erfolgreich abgeschlossene Berufsausbildung oder abgeschlossenes Bachelorstudium im Gesundheitswesen oder im naturwissenschaftlichen Bereich; 2 - 3 Jahre Berufserfahrung wünschenswert; Fundierte Kenntnisse im Qualitätsmanagement und GxP-Bereich sowie Audit-/Inspektionserfahrung von Vorteil; Sicherer Umgang mit MS-Office-Standardsoftware; Bereitschaft zu intensiver Reisetätigkeit mit einem hohen Maß an Flexibilität; Analytisches und lösungsorientiertes Denkvermögen sowie strukturierte und selbständige Arbeitsweise; Team- und Konfliktfähigkeit sowie sehr gute Umgangsformen; Weitere Fremdsprachenkenntnisse wünschenswert; Ihre Benefits: Eine betriebliche Spezial-Ausbildung zum GxP-Auditor; Möglichkeiten zur persönlichen und beruflichen Weiterentwicklung; Abwechslungsreiches sowie anspruchs- und verantwortungsvolles Aufgabengebiet; Angenehme Arbeitsatmosphäre in einem internationalen, dynamischen und leistungsstarken Team; Eine attraktive Vergütung mit zusätzlicher Altersversorgung; Ihre aussagekräftige Bewerbung richten Sie bitte an: CSL Plasma GmbH, PSCQ_SQ, Ute Cherfan, Weender Strasse 75 in 37073 Göttingen oder per Email an ute.cherfan@cslplasma.com Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Plasma CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Posted 30+ days ago

QA Analyst II-logo
DealpathSan Francisco, CA
Dealpath is looking for a QA Analyst II that has expertise in modern web applications and is excited to help drive our product and team forward! This roles requires to be onsite in our San Francisco Office 3 days per week As a QA Analyst II you will bring consistently amazing product flows and experiences to users by working closely with our QA, engineering, product, and design teams. You're excited about this opportunity because you'll: Be an expert of the user experience. Be responsible for the testing and upholding the quality of releases. Manage weekly and monthly releases Define a quality strategy across projects Liaison between product and development teams Gathering and reporting quality metrics for stakeholders Work with the QA Automation team to reduce future testing load. We're excited that you are: Meticulous and detail-oriented - you are able to break down complex product specifications and ensure all aspects are incorporated in the implementation. Organized and process-driven. Able to recognize and surface edge-cases within the product Excited to work in a fast-paced startup environment. Able to communicate and express ideas effectively to all levels of the organization. Passionate about continuous improvement - actively seek out ways to improve processes, methodologies and tools in testing. Qualification: 2+ years of professional software testing experience. Experience testing web and mobile applications. Experience working with tracking tools such as: JIRA, Asana, and Trello. Experience working with testing tools such as: TestRail and Postman. Experience with load and API testing Strong communication and analytical skills For bonus points: Interest in FinTech or Real Estate. Experience in agile testing The Perks & Culture: Medical, dental, & vision insurance coverage. FSA & HSA. Paid Parental Leave. 401(k). Company sponsored commuter benefits. Flexible time off policy. Monthly wellness reimbursement. Hybrid Work Policy, 3 days in office required. The estimated pay range for California candidates is $95,000 - $105,000 base. This position is also eligible for Dealpath's equity plan. Your compensation will be based upon several factors including your experience, qualifications, education, location, and the skills assessed in Dealpath's interview process. Your actual compensation will be confirmed in writing at the time of offer. Dealpath's compensation ranges are determined by current market data, so compensation data posted on our job posts may change as new market data becomes available. About Dealpath: Our mission is to empower real estate investment and capital markets with data and collaboration through purpose-built software. We believe that real estate is driven by people with information to shape the built world. Today, Dealpath is the industry's leading cloud-based deal management platform and expanding rapidly. Recent highlights include: surpassing $10 Trillion of transactions supported on the platform with leading firms like Blackstone, AEW, Oxford, Nuveen, Bridge Investment Group, etc., recognized as the "Top Technology" at Global PropTech Awards, and expanding offices and teams in San Francisco and New York City. We're engineering an industry-defining company to power the largest asset class in the world into the future. Our company is led by an experienced team and backed by a combination of top tier venture capital firms and strategic industry partners including: Blackstone, Nasdaq, 8VC, JLL Spark, WTI, GreenSoil Investments, LeFrak, Milstein, Bechtel, and Morgan Stanley Expansion Capital. We value your voice! If you get excited about solving real business challenges and working closely with other smart folks in a winning culture - we'd love to meet you!

Posted 30+ days ago

QA Manager, Fragrance Manufacturing-logo
OsmoElizabeth, NJ
Who we are at Osmo: Osmo is a digital olfaction company, on a mission to give computers a sense of smell to improve the health and wellbeing of human life. Why? Our sense of smell both enriches and saves lives, and has a deep and direct connection to our emotions and memory. This foundational understanding of smell's impact has directly informed the development of our latest innovation: Generation. Generation is a new kind of fragrance house powered by Olfactory Intelligence (OI) to blend AI with world-class perfumery. It will help brands create emotionally resonant scents faster, more accessibly, and with greater creative clarity. Our technology allows us to explore vast scent possibilities, discover novel ingredients, and design fragrances informed by both data and artistry. Beyond fragrance, Olfactory Intelligence has applications across industries including manufacturing, security, medicine, and more. We believe in the power of automation and thoughtfully applied AI/ML to solve problems beyond the reach of human intuition alone. Osmo is headquartered in New York, NY, with a new facility in New Jersey, and offices in Somerville, MA. Osmo is seeking a QA Manager who will be responsible for overseeing all aspects of quality assurance within our fragrance manufacturing facility, ensuring that all products meet stringent internal and external quality standards, regulatory requirements, and customer expectations. This role will be pivotal in maintaining and enhancing our ISO9001 certified quality management system, implementing robust GMP (Good Manufacturing Practices) across all processes, and developing and enforcing effective sampling protocols. The ideal candidate will be a proven leader with solid quality control experienced in a manufacturing environment, preferably within the fragrance, flavors, cosmetics, or personal care industries. Key Responsibilities Quality Management System (QMS) Leadership: Maintain and continuously improve the company's ISO9001 certified Quality Management System. Develop, implement, and monitor quality policies, procedures, and standards in alignment with regulatory requirements and industry best practices. Lead internal and external audits, ensuring compliance and driving corrective and preventive actions (CAPAs). Manage document control and record-keeping systems for all quality-related activities. Quality Control Oversight: Oversee all quality control experienced activities, including incoming raw material inspection, in-process quality checks, and finished product testing. Develop and implement robust sampling protocols for raw materials, bulk products, and finished goods to ensure representative and accurate testing. Manage and optimize laboratory operations, including equipment calibration, method validation, and data analysis. Investigate and resolve quality issues, customer complaints, and non-conforming products, implementing effective root cause analysis and corrective actions. Team Leadership & Development: Lead and develop a QA program, which fosters a culture of quality, accountability, and continuous improvement. Provide guidance and support to production teams on quality-related matters. Conduct performance reviews and identify training needs for direct reports. Supplier Quality Management: Collaborate with procurement to establish and maintain supplier quality agreements. Conduct supplier audits and evaluations to ensure the quality of incoming materials. Continuous Improvement: Identify opportunities for process improvement and efficiency gains within the quality department and across manufacturing operations. Utilize quality metrics and data analysis to drive data-driven decision-making. GMP Implementation and Compliance: Ensure strict adherence to GMP principles throughout all stages of fragrance manufacturing, including raw material receiving, compounding, filling, packaging, and warehousing. Develop and deliver comprehensive GMP training programs for all relevant personnel. Conduct regular GMP audits and inspections to identify and address potential non-conformances. Required Qualifications Bachelor's degree in Chemistry, Chemical Engineering, Pharmacy, or a related scientific field. Minimum of 5 years of progressive quality control experienced in a manufacturing environment, with at least 3-5 years in a QA Manager or similar leadership role. Demonstrated expertise in implementing and maintaining ISO9001 certified quality management systems. In-depth knowledge of GMP regulations and guidelines within the cosmetic, personal care, or pharmaceutical industries. Proven experience in developing and implementing effective sampling protocols. Strong understanding of analytical testing methodologies and laboratory operations relevant to fragrance manufacturing. Excellent leadership, communication, and interpersonal skills. Strong problem-solving and decision-making abilities. Ways to stand out Proficiency in quality management software and statistical analysis tools is a plus. Benefits: Medical, Dental, Vision, 401K, and more. If this role inspires you we'd encourage you to apply. We are committed to recruiting, developing, and retaining an incredible team optimized for a diversity of thought, background, and approaches. All employment decisions and responsibilities are determined based on current ability and your ability to grow, without regard to race, color, gender identity, sex, sexual orientation, religion, age, marital status, physical, mental, or sensory disability, or any other characteristic protected by applicable law. Recruitment & Staffing Agencies: Osmo does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Osmo or its employees is strictly prohibited unless contacted directly by the Osmo Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Osmo and Osmo will not owe any referral or other fees with respect thereto.

Posted 2 weeks ago

QA Measurement Tech-logo
West Pharmaceutical ServicesWilliamsport, PA
At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future? There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts. Hours for this role - 11:30PM to 8:00AM M-f and every 6th weekend Job Summary Performs visual and dimensional evaluations of manufactured product. Interprets and provides written summaries of the data collected. Provides a resource for manufacturing group with regard to product acceptability based on applicable specifications. Participates as part of the internal audit team. Performs calibration tasks on equipment, gauges, etc. that are part of the Quality System. Reads and interprets WPS and customer blueprints and/or specifications. Participates as part of the Lean Improvement Team as assigned. Essential Duties and Responsibilities Determining product acceptability by performing various visual, functional and dimensional evaluations using various types of measurement devices such as micrometers, calipers, digital or dial indicators, comparators, force testers, and torque testers to determine product acceptability. Providing assistance in the development of sampling plans, as required. Basic understanding of Statistical terminology required to evaluate data and make a determination as to process capability; providing written summarization of study data to engineering or other groups as requested. Using Minitab software to create summarized data and graphs in support of engineering activities. Assisting in the training of manufacturing and support personnel in quality assurance related subjects. Performing internal quality audits as part of the internal audit team. Support new product development working with Engineering to perform dimensional and functional testing. Evaluating current processes for improvement opportunities. Performing in-process inspections in support of the manufacturing group. Ability to evaluate dimensional and functional test results to determine compliance to specifications. Performing calibration tasks for equipment and gauges in support of the Calibration Program. Performing raw material inspection and testing, as back -up to the Quality Assurance Inspector. Verify effectiveness of operator's inspection process by performing selective product sampling audits. Other duties as assigned. Additional Responsibilities Education High School Diploma preferred Preferred 2-year certification in Quality Assurance or commensurate training. Work Experience No min required 1 to 3 years manufacturing experience required Preferred Knowledge, Skills and Abilities Demonstrate proficiency through literacy testing. Must be familiar with computers and various software programs such as Microsoft Word, Microsoft Excel. Master Control and Mattec a plus. Understanding of Statistical Process Control, blueprint reading and use of measuring/testing equipment. Must have excellent interpersonal & problem-solving skills & be able to interface with employees in all levels of the organization; must possess good organization, time-management, negotiating & conflict resolution skills; excellent computer skills (including MS Office experience using Word & Excel) required. Ability to understand an interpret dimensional drawings. Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description License and Certifications Travel Requirements None: No travel required Physical Requirements Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects. Additional Requirements West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening and/or drug screening. #LI-9394

Posted 30+ days ago

QA Technician- Night Shift-logo
Milk SpecialtiesFond Du Lac, WI
At Actus Nutrition, our focus is to create high-quality ingredients designed to optimize health and nutrition. We are passionate and dedicated people. Each day, we collectively explore new, innovative ways to enhance product performance and value through our broad human and animal nutrition portfolios. We offer a comprehensive benefits package which includes medical, dental, vision and life insurance as well as a healthy 401(k) company match program. The Quality Tech has the responsibility for performing analytical procedures on raw materials, in-process samples and finished products as well as assisting with investigation and resolution of operational product issues. Shift: Night Shift- 6:00PM to 6:00AM Pay: $22.00 and up based on experience ESSENTIAL DUTIES and RESPONSIBILITIES: Conduct and interpret lab tests. Package and prepare samples for shipment to third party testing locations. Respond to internal calls to answer technical product questions. Perform laboratory computations leading to accurate data reporting. Troubleshoot lab issues. Conduct routine maintenance on all lab equipment. Contact lab supply vendors. Assist inventory control process. Ensure all laboratory chemical MSDSs are reviewed and filed. Read and properly interpret documents such as lab results, GMP manuals, HACCP programs and procedure manuals. Solve practical problems and comfortably deal in high pressure situations. Possess the ability to interpret a variety of instructions furnished in written and oral forms. Complete routine clerical work such as filing, checking and entering required information into the computer system. Follow plant and laboratory GMPs to maintain a clean work area. Advise operations associates to assure GMPs are followed in the plant. Perform environmental and product testing and communicate results to the plant and corporate management groups as needed. Send timely "Out of Specification" (OOS) notices as needed to internal and appropriate corporate management QUALIFICATIONS: Previous laboratory experience, preferably in a food grade manufacturing facility Strong knowledge of laboratory testing procedures and computer software applications Exceptional analytical and organizational skills Strong interpersonal and communication skills Actus Nutrition is an equal opportunity employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic as defined by federal, state, or local laws.

Posted 30+ days ago

QA Representative - Floor Support-logo
Eli Lilly and CompanyConcord, CA
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Description: The Quality Assurance Representative is responsible for using quality/regulatory knowledge and oversight to provide guidance, consultation and influence in the design, verification, and startup of the manufacturing operations at Lilly's new Concord, North Carolina site. The QA Representative's demonstration of leadership and cross-functional teamwork is essential for ensuring a constant state of cGMP compliance, as well as ensuring regulatory approval of the Concord facility through all design, delivery, verification, qualification, and startup activities. As the site's startup project progresses, the QA Representative will continue to directly support the Device Assembly and Packaging (DAP) manufacturing areas. Responsibilities include: Maintains knowledge of Current Good Manufacturing Practices (cGMP), including good documentation practices (GDP), data integrity and regulatory compliance Fosters a strong quality culture by maintaining open communication, promoting teamwork and encouraging employee participation in the working group Guides others in Quality Management System (QMS) topics such as exceptions, observations, deviations, corrective action/preventive action (CAPA), change controls, document creation/revisions, etc. Supports the definition and execution of inspection readiness activities including support of site self-inspections Resolves or escalates any compliance issues to the project, site and Quality Management Functions as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas employing QbD and QRM principles and ensuring the integration of Global Quality System requirements into the design Consults with Network and Global Quality groups to ensure a consistent and compliant approach is executed during the startup phase Actively participates in required design reviews and final design qualification activities Provides technical and quality review/approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures Provides quality oversight for the verification and qualification of the manufacturing buildings, including review of test cases, test execution, discrepancy resolution, etc. Works with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross-functional support with focus on the Manufacturing areas Supports the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other project staff Leads project initiatives needed in support of the startup project and Quality function Maintains a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals Technical Skills: Adept at technical writing for appropriate audience - written communication is clear, concise and technically accurate (batch record documentation, description of quality observations, investigation findings and results, etc.) Application of technical knowledge to consistently and appropriately classify product defects per defect classification procedure. Accute attention to detail with ability to lead others in how to identify potential impact to product quality and take the correct actions to ensure any risk to quality has been appropriately addressed and documented. Basic Requirements: Bachelor's degree Ability to work 12-hour shifts on a 2-2-3 production schedule, with additional hours when required Ability to work onsite in Concord, NC (not eligible for remote work) Additional Skills/Preferences: Experience within the pharmaceutical, medical device, or other regulated manufacturing industry preferred Experience as a Quality professional supporting pharmaceutical and/or medical device manufacturing preferred Knowledge and use of US, EU, Japan and other regulations in pharmaceutical manufacturing Ability to communicate with cross-functional teams including good oral and written communication skills Ability to work independently as a Quality SME with minimal supervision Proficiency with computer systems including Microsoft office products, Trackwise, etc. ASQ Certification CSQA (Computer Systems Quality Assurance) experience Experience with manufacturing equipment preparation, formulation, filling, visual inspection, device assembly, packaging, utilities, facilities, maintenance, and warehouse management Experience with Manufacturing Execution Systems. Use of KNEAT - or other electronic validation software Technical writing and review experience Technical aptitude and ability to train/mentor others Experience with C&Q/Verification and Validation oversight including automation and computer systems validation Must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or R1-R3. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $162,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Posted 1 week ago

Supv, Food Safety QA-logo
Performance Food GroupSpringfield, MA
Job Description We Deliver the Goods: Competitive pay and benefits, including Day 1 Health & Wellness Benefits, Employee Stock Purchase Plan, 401K Employer Matching, Education Assistance, Paid Time Off, and much more Growth opportunities performing essential work to support America's food distribution system Safe and inclusive working environment, including culture of rewards, recognition, and respect Position Summary: The FSQA Supervisor is responsible for the quality, food safety and esthetics of the product at the meat plant. Follows through on set processes and ensures adherence to good manufacturing practices (GMP), food safety and product quality standards. Responsible for continuous improvement in our food safety practices and policies. Has oversight of the plant's sanitation team and be tasked with continuous improvement over sanitation practices and procedures. Position Responsibilities: Responsible for monitoring critical control points (CCP) Responsible for monitoring product food safety and quality throughout the manufacturing process. Responsible for performing sanitation verification and allergen testing on equipment and other areas. Responsible for the correct recording and filing of all relevant record logs and Documentation. Ensures employees are following all Food Safety and worker safety practices while educating them on continuous improvement. Perform pre-operational inspections on Products, Equipment and Machinery. Oversee the sanitation team to improve practices and procedures. Performs other related duties as assigned. Schedule: Monday thru Friday 7:00am- 5:00pm with one week a month at night Required Qualifications High School Diplomas/GED 6 months- 1 year Food Safety experience Ability to work independently as well as interact with other departments. Strong verbal and written communications skills. Computer proficient. Basic knowledge of Microsoft Outlook, Excel, Word and Access. Ability to organize, prioritize and meet critical tasks and deadlines in a fast-paced work environmental. Ability to accept changing work demands and seek opportunities to improve food safety systems. Able to present to large groups. Preferred Qualifications Bachelors: 3- 5 years' experience

Posted 1 week ago

Software QA Test Dev Engineer-logo
NvidiaSanta Clara, CA
We are seeking a qualified Software QA Test Development Engineer to join our GPU SWQA team. The successful candidate will demonstrate substantial experience with AI technologies for automation of test cases, as well as an in-depth understanding of both Windows and Linux operating systems. Comprehensive knowledge of system architecture is essential, along with a strong command of PC I/O architecture and common bus interfaces, including PCI-E, USB, and SATA. Familiarity with specifications pertaining to general PC-Architecture components will be regarded as a valuable asset. What you'll be doing: Design and implement automated tests incorporating AI technologies for NVIDIA's device driver software and SDKs on various Windows and Linux operating systems. Build tools/utility/framework in Python / C / C++ which would help automate and optimize the testing workflows in GPU domain . Develop and implement automated and manual tests, analyze results, identify and report defects. Rigorously drive test automation initiative. Build innovative ways to automate and expand our software testing. Expose defects and constraints; Isolate and debug the issue(s) and find the root cause; Contribute to the solution and drive to closure. Measure code coverage for the software under test, analyze and drive code coverage enhancements. Develop applications and tools that accelerate development and test workflows and write fast, effective, maintainable, reliable and well documented code. Generate and test compatibility across a range of products and interfaces and validate different key software applications across a test matrix designed to test both breadth and depth. Provide peer code reviews including feedback on performance, scalability and correctness. Effectively estimate and prioritize tasks in order to create a realistic delivery schedule. You will have the opportunity to work on challenging technical and process issues and work closely with leadership to report progress, generating effective and actionable reports. This is an onsite position located at the Santa Clara HQ office. What we need to see: B.S / B.Tech/M.S in Computer Science / Electronics & Telecommunication with strong academics or equivalent experience. 5+ years of programming experience in Python/C/C++ with experience in applying Object-Oriented Programming concepts. Hands-on knowledge of developing Python scripts with application development concepts like dictionaries, tuples, RegEx, PIP etc. Working experience with databases and storage technologies like SQL, MongoDB and Elasticsearch. Good understanding of OS fundamentals, PC Hardware fine-tuning in those areas Good Communication skills (interpersonal and across teams). Excellent analytical and problem-solving skills. Very organized, proactive, and has good learning ability. The ability to work with a team of engineers in a fast-paced environment Ways to stand out from the crowd: Good problem-solving skills (solid logic to apply in isolation and regression of issues found). Substantial experience with AI-driven automation Ability to work in a distributed team environment. Good written communications skills are crucial. Your base salary will be determined based on your location, experience, and the pay of employees in similar positions. The base salary range is 136,000 USD - 212,750 USD for Level 3, and 168,000 USD - 264,500 USD for Level 4. You will also be eligible for equity and benefits. Applications for this job will be accepted at least until August 23, 2025. NVIDIA is committed to fostering a diverse work environment and proud to be an equal opportunity employer. As we highly value diversity in our current and future employees, we do not discriminate (including in our hiring and promotion practices) on the basis of race, religion, color, national origin, gender, gender expression, sexual orientation, age, marital status, veteran status, disability status or any other characteristic protected by law.

Posted 30+ days ago

B
Bally's CorporationJersey City, NJ
Who we are Bally's Corporation is a global casino-entertainment company with a growing omni-channel presence. It currently owns and manages 15 casinos across 10 states, a golf course in New York, a horse racetrack in Colorado, and has access to OSB licenses in 18 states. It also owns Bally's Interactive International, formerly Gamesys Group, a leading, global, online gaming operator, Bally Bet, a first-in-class sports betting platform, and Bally Casino, a growing iCasino platform. With 10,600 employees, the Company's casino operations include approximately 15,300 slot machines, 580 table games and 3,800 hotel rooms. Upon completing the construction of a permanent casino facility in Chicago, Bally's will own and/or manage 15 casinos across 10 states. Bally's also has rights to developable land in Las Vegas post the closure of the Tropicana. Its shares trade on the New York Stock Exchange under the ticker symbol "BALY". Well, what about the team? We're looking for a QA Engineer with strong problem solving and analytical skills to work alongside QAs within the team and coordinating QA effort across the different teams involved in a project/programme. This is both a vital and challenging role with a large amount of responsibility. You will be encouraged to form strong relationships with your team and with other teams in the company. At the same time, it requires a strong knowledge of the SUT, to try to identify gaps and flows that needs to be checked in E2E testing. The successful candidate will be enthusiastic, dynamic, business focused, with good communication skills and excel at problem solving. Applicant should be able to create test strategies from scratch, highlight risks, dependencies and impediments, and create dashboards and reports to document the different tasks. An enthusiasm for learning new skills is desirable, as you will be expected to follow best software practices, as well as promote QA and to help continually improve QA working practices. So, what will you be doing? Developing and owning the Test Strategy- defining the expectations and standards that development teams and QAs should meet. Collaborating with Staff Engineers and Product to develop and approve Test Plans for initiatives. Actively contributing during the analysis and refinement process to shape the appropriate test approach. Fostering a culture of Quality across the department. Acting as a quality advocate and work closely with other QA Leads in the company encouraging collaboration across teams. Assuming responsibility and accountability for the creation, collection, and maintenance of our Quality KPIs for the Platform. Championing, defining and driving initiatives to increase the efficiency and effectiveness of our QA processes, tools, and capabilities in all areas. Supporting and contributing to the testing and bug fixing phases of initiatives across the domain Facilitating efficient QA processes such as effective bug writing, bug triage, prioritization, severity, and risk-based testing approaches platform-wide. Leveraging your skills and experience to balance technical, people, process, and delivery aspects. Championing and promoting a culture of continuous improvement across the software delivery lifecycle. Possessing leadership skills that ignite inspiration and guidance within a team, steering them towards excellence. And what are we looking for? Possess exceptional communication skills, both interpersonal and written. Demonstrate a proactive mindset and strong sense of ownership. Exhibit expertise in designing and implementing comprehensive test strategies for full-stack testing. Have hands-on experience with build and integration pipelines (e.g., Jenkins, GoCD, GitLab CI/CD). Be skilled at refining and validating requirements and specifications, ensuring clarity and testability. Possess strong analytical skills and deep understanding of complex system architectures. Have a solid understanding of the test pyramid and various testing methodologies, including unit, API, UI, performance. Demonstrate exceptional ability to analyze detailed business requirements. This is what you'll get Different benefits packages are tailored to fit each location, but here's a taste of what may be on offer Annual vacation Annual bonus 401(k) matching Health insurance Home office allowance Flexible Working At Bally's Interactive, we believe in the power of collaboration and working together in a shared space, as well as the benefits of working from home. We champion hybrid working wherever we can, offering a flexible blend of working in the office 3 days a week and from home twice a week. DNA / Values At Bally's Interactive, we are driven by a set of core values that we like to call our DNA. We strive to embody our DNA and keep them at the heart of everything we do! We are Always Ready to embrace change, adapt, and do what it takes to delight our customers. We believe that You Make the Difference, which is what gives our players the best experience and keeps them coming back. We are All One Team, looking out for each other, respecting diversity while connecting through a common purpose. Our teams are Learning Every Day by showing constant curiosity and the drive to learn from successes, mistakes, new experiences, and the people around us. At Bally's we Love to Lead by thinking differently, seeking innovation, and always looking for ways to raise our game. Equal Opportunities At Bally's Interactive, we are committed to promoting equal opportunities in employment and working conditions. Diversity, Equity and Inclusion are important to us, and we encourage a culture where everyone can be themselves at work. We believe passionately that employing a diverse workforce is central to our success, this is our superpower. We do not discriminate against employees or job applicants on the basis of race, colour, nationality, ethnic or national origin, age, sex or sexual orientation, gender reassignment, religion or belief, marital or civil partner status, pregnancy or maternity, political opinion or disability. Salary range: $90,000 - $110,000 USD #LI-OP1

Posted 2 weeks ago

QA Technician-logo
U-HaulTempe, AZ
Return to Job Search QA Technician Job Description Perform dimensional, mechanical and visual inspections to determine the acceptability of parts in the First Article process. Perform product test evaluations on production parts and assemblies to determine their condition against approved drawings, established standards, and fit for intended use applications. Must be capable of interpreting drawings and blueprints to accomplish a specific task. Must have exceptional written and oral communication skills and be able to interact with a variety of people. Computer skills (intermediate knowledge of MS Office programs such as Word, Excel) are required. Duties Perform dimensional and visual inspection requirements utilizing drawings, OEM manuals, and/or written instructions Record and document findings legibly and precisely Interpret and analyze test requests to prepare test procedures for testing. Perform product evaluation testing on parts and sub-assemblies for monthly/yearly verification/certification. Record and analyze requested test data from test results. Utilize test equipment to produce, regulate, and record effects/results of actual or simulated conditions such as stress, vibration, pressure, accelerations, salt exposure, humidity, temperature, QUV, material hardness, abrasion, etc. for QC testing/inspection. Measure physical properties of test specimens following a prescribed series of operations on various types of test machines. Reasonable and predictable attendance is required Complete work to meet test/inspection schedules, work OT as needed. Experience Must be able to read, comprehend, and interpret dimensional drawings, technical documents, and manuals, ensuring that products and parts meet quality standards. Proficient use of calipers, gauges, micrometers, dial indicators, optical comparator, multi meter, and other mechanical, electrical, and electronic test gear for performing fine measurements and test functions. Write test outlines and test reports on inspection and test data. Knowledge of basic math and computer skills for measuring, calibrating, and calculating specifications for quality control testing. Must be able to use specialized tools (hand & power) and operate sophisticated electronic instrumentation for in-house lab tests. Must be proficient in Microsoft Excel and Word. 3+ Years' experience performing as an accomplished QC inspector or equivalent. Education High school degree with post secondary vocational program desired. May be substituted with experience U-Haul is an equal opportunity employer. All applications for employment will be considered without regard to race, color, religion, sex, national origin, physical or mental disability, veteran status, or any other basis protected by applicable federal, provincial, state, or local law. Individual accommodations are available on requests for applicants taking part in all aspects of the selection process. Information obtained during this process will only be shared on a need to know basis.

Posted 30+ days ago

Principal, QA- IDM (R1 - R4)-logo
Eli Lilly and CompanyIndianapolis, IN
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Eli Lilly and Company seeks Principal, QA- IDM (R1 - R4) to define compliance requirements for project teams and participate in identifying specific software deliverables for SaMD (Software as a Medical Device) and SiMD (Software in a Medical Device). Accountable for QA oversight of product development, release, and life cycle management of MMA-mobile medical applications used in digital health. Ensure quality management system compliance by providing input and updates to procedures based on internal and regulatory requirements and drive incident investigations to identify and implement corrective and preventive actions. Ensure development deliverables are complete by conducting phase audits or other audits. Define, implement, and monitor quality design controls for custom developed software and off-the-shelf software management toolsets. Accountable for quality governance and oversight, including change management. #LI-DNI Position requires a Bachelor's degree in Biomedical Engineering, Computer Science, or a related field and 2 years of experience with regulated software and/or firmware commercialization. Experience must include a minimum of: 2 years of experience with risk management using ISO 14971 and ANSI 62304; 2 years of experience with authoring standard operating procedures to standardize design control processes and maintain compliance with ISO 13485; 2 years of experience with performing regulatory compliance reviews and similar auditing; 2 years of experience with design verification and design validation; 2 years of experience with developing and communicating software metrics, including trends, anomalies, requirements testing, and test suite status; 2 years of experience with working with software development teams under multiple product development projects; and 2 years of experience with software product development from concept phase to project closure. Telecommuting benefit available. Up to 10% domestic and international travel required. #LI-DNI Job location: Indianapolis, IN. RATE OF PAY: $113,232.00 per year. To apply, please visit https://jobsearch.lilly.com/ and enter job requisition number R-91514 when prompted. Alternatively, please send your resume, cover letter, and a copy of the ad to: Matthew Tenaglio, Lilly Corporate Center, Indianapolis, IN 46285. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $113,232 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Posted 1 week ago

QA Lead (Second Shift)-logo
AssurantMount Juliet, TN
As a Quality Assurance Lead, you will inspect, test, and audit product processes following set procedures and exercising reasonable judgment. Attention to detail is essential and requires your effective performance of a variety of quality assurance and inspection operations. This is an onsite role in our Mt Juliet, TN office with a schedule of Monday - Thursday, 4:30PM - 3AM. What will be my duties and responsibilities in this job? Perform Quality Assurance Lead operations (within procedural verbatim compliance) related to the test and inspection of electronic devices Perform quality inspection operations following instructions and pre-established guidelines Creating work instruction for the Quality department, in collaboration with the documentation team and Quality Supervisor Provide training to new and; or existence employees on 6S and work instruction Participate in weekly department status update meeting with department supervisor Provides training to team members Tracking weekly tasks and metrics Provide ANSI/AQL results to stakeholders Establish and evolve formal QA processes, ensuring that the team is using industry-accepted best practices Oversee all aspects of quality assurance including establishing metrics, applying industry best practices, and developing new tools and processes to ensure quality goals are met Act as key point of contact for all QA aspects of releases, providing QA services and coordinating QA resources internally and externally Lead and mentor QA team members, as well as manage outside contract testers Develop and execute test, plans and procedures (manual and automated) Entering relevant data and audit/inspection results in our computer database Provides process improvement feed back Work on multiple programs and in multiple QA functional areas Serve as a resource for questions to other co-workers when supervisor is unavailable Documenting relevant facts and information to support work performed Participating in continuous improvement and team building activities Maintain productive working relationships with all team members Performing other duties as assigned What are the requirements needed for this position? High school diploma or equivalent Minimum of 3 years demonstrated quality experience Cross-training in two or more jobs areas (including current) are required Ability to be a certified trainer in multiple areas Full understanding of the work process and flow Ability to use a personal computer and enter data with basic software Ability to work independently Establish and evolve formal QA processes, ensuring that the team is using industry-accepted best practices Lead and mentor QA team members What other skills/experience would be helpful to have? One year or greater of previous experience working in a manufacturing environment One year of greater of Quality Assurance/Inspection experience Any verbatim written procedure compliance experience Familiar with basic electronic test equipment Strong attention to detail Ability to handle multiple priorities simultaneously Ability to work independently and in a team environment Ability to interact effectively and positively with all levels of company personnel Pay Range: $18.65 - $29.84 Any posted pay range considers a wide range of compensation factors, including candidate background, experience and work location, while also allowing for salary growth within the position. Expected application deadline is 09/01/2025 If date is blank then this is a pipeline requisition, and we will continue to collect applications on an ongoing basis. Helping People Thrive in a Connected World Connect with us. Bring us your best work and your brightest ideas. And we'll bring you a place where you can thrive. Learn more at jobs.assurant.com. For U.S. benefit information, visit myassurantbenefits.com. For benefit information outside the U.S., please speak with your recruiter. What's the culture like at Assurant? Our unique culture is a big reason why talented people choose Assurant. Named a Best/Great Place to Work in 13 countries and awarded the Fortune America's Most Innovative Companies recognition in 2023, we bring together top talent around the world. Although we have a wide variety of skills and experiences, we share common characteristics that are uniquely Assurant. A passion for service. An ability to innovate in practical ways. And a willingness to take chances. We call our culture The Assurant Way. Company Overview Assurant is a leading global business services company that supports, protects, and connects major consumer purchases. A Fortune 500 company with a presence in 21 countries, Assurant supports the advancement of the connected world by partnering with the world's leading brands to develop innovative solutions and deliver an enhanced customer experience through mobile device solutions, extended service contracts, vehicle protection services, renters insurance, lender-placed insurance products, and other specialty products. Equal Opportunity Statement Assurant is an Equal Employment Opportunity employer and does not use or consider race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by federal, state, or local law in employment decisions. Job Scam Alert Please be aware that during Assurant's application process, we will never ask for personal information such as your Social Security number, bank account details, or passwords. Learn more about what to look out for and how to report a scam here.

Posted 3 weeks ago

Quality Assurance Supervisor/Sr. Supervisor - QA Analytical-logo
KBI BiopharmaDurham, NC
Job Summary: This position is primarily responsible for supervising a staff that supports the coordination, tracking and review of Test Sample Plans (TSPs) and the associated in-process data associated with batches manufactured at KBI. This position is also responsible for the review and approval of release and stability test data as needed. Experience in the review and approval of laboratory investigations and deviations is also beneficial to this position Responsibility: 1) Responsible for the coordination and tracking of test sample plans(TSPs) and associated in process data. Report out metrics to relevant operational meetings and/or client meetings. (15%) 2) Perform compliance review of test sample plans and associated in-process data. (55%) 3) Supervises direct reports providing coaching and mentoring. (5%) 4) Develop and/or support training materials for QA review of Test Sample Plans. (5%) 5) Work with functional areas to improve the lifecycle of Test Sample Plan review cycle times and batch release dates. (5%) 6) Responsible for the review of release and stability data as needed. (5%) 7) Responsible for the review and approval of laboratory investigations, deviations, and CAPAs. (5%) 8) Attend relevant operational meetings in support of disposition activities. Support Client Audits and Regulatory Inspections as required. (5%) Minimum Requirements: 1) Knowledge, Skills, Abilities: BS in scientific field with 15+ years' experience or MS and 10+ years' experience in a QA cGMP regulated environment within biopharmaceuticals or equivalent. Experience with quality systems to include batch release review, batch disposition of biopharmaceuticals, and lab investigations and deviations. Knowledge of US and EU guidelines is a plus. 2) Language Ability Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients and customers. 3) Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 4) Math Ability Basic math skills are required. Ability to apply concepts of basic algebra and statistics. 5) Physical Demands Sitting at a computer for long periods of time. 6) Computer Skills Word processing, Database, Spreadsheets, Power Point, Internet, E-mail, Calendar Management 7) Equipment Use Computer and telephone KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 30+ days ago

B
Bunzl Plc.Romeoville, IL
Bunzl Distribution is seeking a Technical QA Manager with a strong data engineering mindset to lead quality across our Business-to-business (B2B) eCommerce and distribution platforms. In this role, you will build our Quality Assurance capability from the ground up - shifting from consultant-reliant testing to an AI-powered, developer-integrated, automation-first QA practice. The ideal candidate is a hands-on builder who can co-author unit tests, use GitHub Copilot Pro+, implement AI-based testing tools, and drive performance and functional automation in a fast-paced environment. They will be embedded directly with the engineering team, participating in standups, sprint planning, and code reviews. Success in this role means taking ownership of quality at the source, writing tests alongside developers, introducing reusable QA libraries, and ensuring performance, stability, and scalability are never compromised. This is a role for someone who treats AI as a coding partner, builds tools to eliminate manual QA, and becomes a technical voice in shaping testable architectures. This is a hybrid role out of our Chicago, IL (Morton Grove) office. Expectation is to be in the office 3-4 days per week. Responsibilities: Define and implement a scalable test strategy and automation architecture across unit, API, UI, and performance layers. Collaborate with developers to design testable systems and write unit tests using TDD practices. Use AI tools like GitHub Copilot Pro+, CodiumAI, or Diffblue to generate, refactor, and improve test coverage and assertions. Develop and maintain reusable test frameworks for both desktop and mobile applications. Execute performance and load testing using JMeter, k6, or AI-enhanced tools such as Tricentis NeoLoad, LoadNinja, or Predator. Analyze business and technical requirements to create and maintain test cases, test plans, and test reports. Build internal tools or libraries to reduce repetitive work and increase QA reusability and intelligence. Track and manage issues using bug tracking tools and report on test progress through weekly QA metrics. Lead QA efforts across multiple projects/releases concurrently, including integration with AS400 or ERP systems. Provide training and mentorship on testing best practices and AI/automation standards to other team members. Raise red flags early and provide strategic QA input into project risk, quality, and release readiness. Requirements: High school diploma or GED equivalent required Bachelor's degree in computer science or related field 8+ years of QA or SDET (software development, engineer and test) experience with strong automation and coding skills Solid programming experience in JavaScript, Python, or Java (with knowledge of .NET a plus) Hands-on experience in TDD (test driven development), unit testing frameworks (e.g., Jest, JUnit, PyTest), and co-authoring tests with developers Experience with GitHub Copilot Pro+, CodiumAI, or similar AI test coding assistants Test automation experience using Cypress, Playwright, Selenium/WebDriver, Postman, and RestAssured Experience in performance testing using JMeter, k6, or cloud-based/AI performance testing platforms Deep understanding of B2B eCommerce systems, distribution logic, and ERP integration (e.g., AS400) Strong familiarity with CI/CD pipelines (GitHub Actions, Azure DevOps, GitLab CI) Knowledge of test data design, XML/JSON, and SQL for backend validation. Preferred Skills: Built internal testing tools or reusable automation libraries Experience in AI/ML model validation or prompt testing Cloud-native testing exposure (AWS, Azure, GCP) Performance observability and root cause diagnostics Bunzl Salary range for this role is $100,000- $130,000/year based on experience, education and location. What are you waiting for? A new career awaits you with endless opportunities. Bunzl is a global leader in the Cleaning & Hygiene, Food Processing, Grocery, Health Care, Non-Food Retail, and Safety industries. We have grown both organically and through acquisitions to sales in excess of $10 billion. Bunzl North America is headquartered in St. Louis, Missouri. Bunzl North America owns and operates more than 100 warehouses and serves all 50 states, Puerto Rico, Canada and parts of the Caribbean and Mexico. With more than 5,000 employees and 400,000 plus supplies, Bunzl is regarded as a leading supplier in North America. Bunzl Distribution offers competitive salaries, a comfortable work environment, and a full range of benefits including a 401k with a company match. Bunzl Distribution has a tradition of commitment to equal employment opportunity. It is the established policy to attract and retain the best qualified people without regard to race, color, religion, national origin, sex/gender (including pregnancy), sexual orientation, age, disability or veteran status as provided by law.

Posted 4 days ago

I
INCOG BioPharmaFishers, IN
Working closely with the QA Operations Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps. The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Associate will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions: Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor. Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc. Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations. Support other QA personnel with batch record reviews, material release, etc. Prioritize and coordinate his/her time in balancing production timelines with product quality assurances. Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution. Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. Ability to manage multiple projects in a fast-paced environment. Special Job Requirements: This position will support primarily third shift (11:00pm-7:30am) with occasional weekend support, dependent on operations' needs. Bachelor's Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.) Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment. Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.. Understanding of Good Documentation Practices (GDPs) and its criticality. Excellent written and verbal communication skills. General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: Hands-on experience with aseptic manufacturing. Experience with Continuous improvement, Six Sigma, and/or Lean principles. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Posted 30+ days ago

KBI Biopharma logo

QA Specialist I/Ii, QA Manufacturing

KBI BiopharmaBoulder, CO

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Job Description

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.

Position Summary:

The Quality Assurance Specialist I/II Manufacturing is responsible for assuring products, processes, facilities, documentation, and systems conform to quality standards, internal procedures, systems, and governmental regulations. This position will provide a broad range of quality oversight for activities that support bulk drug substance manufacturing. This position will be responsible for review and approval of executed procedures, equipment logs, and batch records supporting all aspects of cGMP operations.

Position Responsibilities:

  • Perform compliance review on the following executed records: batch and solution record (includes on-the-floor review of records) and associated forms, in-process data, and applicable logs

  • Author new and revised Standard Operating Procedures, Forms/Logs, Master Batch Records and Solution Records

  • Support Manufacturing changeover process

  • Work directly with manufacturing, the laboratory and other departments responsible for GMP activities to resolve deviations and other compliance issues in a timely manner

  • Author, review, and approve deviation investigations

  • Support client batch record review process

  • Support QA Raw Material group with release of raw materials as needed

  • Able to react to change productively and handle other essential tasks as assigned.

Position Requirements:

QA Specialist I: Bachelor's degree and 2 years of experience

QA Specialist II: Bachelor's degree and 6 years of experience

Experience in a cGMP QA environment or equivalent is preferred.

Salary Range:

Specialist I: $55,000 - $75,900

Specialist II: $74,000 - $102,300

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.

About KBI:

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

Please note: Our pre-employment drug screening includes substances that are legal in Colorado but remain illegal under federal law, such as marijuana. A positive result for these substances may result in disqualification from employment consideration.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Automate your job search with Sonara.

Submit 10x as many applications with less effort than one manual application.

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