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QA Specialist/Senior QA Specialist, Manufacturing Quality-logo
QA Specialist/Senior QA Specialist, Manufacturing Quality
GenentechHillsboro, Oregon
Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 production streams, which combine to produce millions of units of life-saving medicine every year to patients around the world. The Opportunity: In this exciting role, you will provide direct manufacturing quality oversight at HTO. As part of a dynamic and inclusive team, you will partner with manufacturing and other stakeholders at the site and in the network to supply patients. You will apply knowledge of aseptic drug product manufacturing processes, of health authority expectations and industry standards. You will act as a mentor and coach for the organization. You will act as key quality contact to manufacturing for discrepancy management, line support and batch review for commercial and launch products. You will provide quality oversight related to operational activities, procedures and processes. You will ensure that investigations are accurate, include appropriate corrective actions, and follow regulations, industry guidelines and company standards. You will apply your in-depth practical and conceptual knowledge in the manufacturing and quality functional areas at the site and within the company network. You will support internal cGMP audits and Health Authority inspections as a technical resource and quality subject matter expert. You will develop new approaches to complex problems. You will lead coordination and issue resolution across HTO Manufacturing Operations, support groups and/or projects (e.g. Operations Teams) as needed. You will be responsible for setting the strategic direction and framework of one or multiple programs within HTO Quality in the areas of process development, process improvement, quality and compliance. You will own the deliverables within the established programs and lead teams in their execution in line with the site strategy. You will be accountable for managing key operational support activities related to product transfers and new equipment/process start-up (manufacturing readiness and process design, documents, engineering runs, equipment set up, etc.). Who you are: You hold a Bachelor’s degree (preferably within the Life Sciences or Engineering) For a QA Specialist, you have at least 5 years of experience in the pharmaceutical industry. For a Senior QA Specialist, you have at least 8 years of experience in the pharmaceutical industry. You are a strong problem-solver and have the demonstrated ability to troubleshoot and resolve process-related issues, ensuring efficient operations and regulatory compliance. You possess a deep understanding of safety, quality systems, and quality assurance concepts including the application of current Good Manufacturing Practices (cGMPs) in aseptic processing and production. You have a solid understanding of aseptic processing principles, regulations, and industry guidelines relevant to biologics processing, including knowledge of quality assurance principles, quality systems, microbiology, and sterility assurance. Your interactions exhibit tactful and effective communication skills as they often involve complex and sensitive information. You are able to gown into production space. Preferred: You have a Master’s degree (preferably within the Life Sciences or Engineering) You have experience in nPFS (nested pre-filled syringe) filling You have experience in medical devices The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $75,000 - $139,400 for the QA Specialist level and $91,100 - $169,100 for the Senior QA Specialist. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Link to Benefits This position is eligible for relocation benefits. It is not eligible for full time remote work arrangements. #gnehtoquality Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants .

Posted 3 weeks ago

QA Technician-Acorn QA 2Nd Shift-logo
QA Technician-Acorn QA 2Nd Shift
Farmer FocusHarrisonburg, VA
Who We Are and What We Do Farmer Focus's mission is to promote and protect generational family farms by shifting farm-level decision-making and chicken ownership back to farmers and empowering them to farm the way they know is best. We are committed to consistently producing 100% organic and humanely raised chicken that is better for people, the planet, and animals. Our culture is rooted in servant leadership, and we live by our Farmer Focus CARES values: Community, Accountability, Respect, Excellence, and Stewardship. Who We Are and What We Do Farmer Focus's mission is to promote and protect generational family farms by shifting farm-level decision-making and chicken ownership back to farmers and empowering them to farm the way they know is best. We are committed to consistently producing 100% organic and humanely raised chicken that is better for people, the planet, and animals. Our culture is rooted in servant leadership, and we live by our Farmer Focus CARES values: Community, Accountability, Respect, Excellence, and Stewardship. Job Description Responsible for compliance of food safety systems along with quality programs, policies, procedures, and processes that are designed and necessary to ensure food safe products. Comply with government regulations and adhere to quality standards and specifications for Shenandoah Valley Organic. Essential Duties & Responsibilities Assure finished product meets company standards. Assure product throughout production process is carried out in accordance with plant HACCP, SSOP and GMP procedures. Assure sanitary conditions in production areas are maintained in accordance with regulatory requirements. Accurately record findings observed during verification and pre-shipment review checks. Perform pre-operational and operational sanitary inspections. Perform HACCP and GMP related tasks. Assist in the process of product samples preparation and shipping. Assist USDA inspectors if required. Collect product samples during operation. Generate daily QA documentation. Support production in the development of, effectiveness, and the implementation of corrective actions. Additional task as assigned by supervisor. . Skills and Knowledge High School Diploma or G.E.D required. 1-2 years' experience in poultry production Verbal communication skills, able to explain concepts. Excellent reading comprehension and writing skills, including good grammar and spelling. Self- Starter, able to complete tasks under minimal supervision at times. Able to follow the directions of lead, supervisor, and manager. Team-Player Strong analytical ability and math skills. Ability to organize, plan, and complete work in a timely manner. Labeling experience (not required, but desired). Must be able to read and write English. Bi-lingual a plus. Physical Demands Color vision, corrected to 20/20 Ability to write notes in English. Sitting 10%Walking 60% Standing 30% Lifting to 50 Lbs. Work Environment: Required to access the poultry production environment. Must be able to tolerate the varying heat, wet, and chill of the plant. Hearing and eye protective equipment required in the production area. Required to wear hair and beard nets in the production area. Farmer Focus is committed to the principles of equal employment and to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is our intent to maintain a work environment that is inclusive and equitable, free of harassment, discrimination, or retaliation based upon an individual's age, race (including traits historically associated with race, which includes hair texture, hair type, and protective hairstyles such as braids, locks, and twists), color, national origin, ancestry, religion, sex, sexual orientation (including transgender status, gender identity, or expression), pregnancy (including childbirth, lactation, and related medical conditions), physical or mental disability, genetic information (including testing and characteristics), military status (including status as a uniformed servicemember, a veteran, or dependent of a servicemember), or any other status protected by federal, state, or local laws. Farmer Focus is dedicated to the fulfillment of this policy regarding all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay and other compensation, termination, and all other terms, conditions, and privileges of employment. Farmer Focus is committed to the principles of equal employment and to complying with all federal, state, and local laws providing equal employment opportunities, and all other employment laws and regulations. It is our intent to maintain a work environment that is inclusive and equitable, free of harassment, discrimination, or retaliation based upon an individual's age, race (including traits historically associated with race, which includes hair texture, hair type, and protective hairstyles such as braids, locks, and twists), color, national origin, ancestry, religion, sex, sexual orientation (including transgender status, gender identity, or expression), pregnancy (including childbirth, lactation, and related medical conditions), physical or mental disability, genetic information (including testing and characteristics), military status (including status as a uniformed servicemember, a veteran, or dependent of a servicemember), or any other status protected by federal, state, or local laws. Farmer Focus is dedicated to the fulfillment of this policy regarding all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay and other compensation, termination, and all other terms, conditions, and privileges of employment.

Posted 4 days ago

QA+QC Manager (Beauty Products)-logo
QA+QC Manager (Beauty Products)
Thrive CausemeticsLos Angeles, CA
Location: In-Office 4 days/week in Playa Vista, CA HQ Who We Are: Thrive Causemetics is Bigger Than Beauty™: We are an independent, female-owned beauty brand that creates high-performance vegan cosmetics and supports a community of giving. All of Thrive Causemetics' products are free of parabens and sulfates, in addition to being 100 percent cruelty-free. Through its Bigger Than Beauty™ program, every product purchased results in a donation to help communities thrive. Thrive Causemetics is dedicated to fostering a collaborative and cross-functional workplace where everyone’s voice matters. We are committed to being pioneers in creating a culture of wellness. Together, we prioritize a strong work ethic while maintaining a positive, exciting environment where people are passionate about what they do. Who We Are Looking For: We are seeking an experienced QA/QC Manager to lead quality assurance and quality control efforts across our color cosmetics and skincare product lines. This critical role will oversee all aspects of product quality, ensuring that our formulations, packaging, and finished goods meet the highest standards of safety, performance, and regulatory compliance. As the QA/QC Manager, you will work closely with internal teams, contract manufacturers, and external testing partners and warehouses to uphold our brand’s reputation for exceptional quality. This role will require occasional travel to physically audit inventory and visit CMs to inspect product quality. What You Will Be Doing: Develop, implement, and maintain a robust Quality Management System (QMS) tailored to the needs of the business. Establish and document standard operating procedures (SOPs) for product development, manufacturing, and testing processes. Conduct audits of contract manufacturers and suppliers to ensure adherence to quality standards, GMP (Good Manufacturing Practices), and regulatory compliance. Collaborate with R&D and Product Development teams to integrate quality protocols early in the product lifecycle. Oversee the testing of bulk formulations, and finished products to ensure consistency, safety, and efficacy. Manage third-party labs and testing facilities for microbiological, stability, and compatibility testing. Create and implement incoming inspection protocols for packaging, raw materials, and finished goods. Investigate and resolve quality issues, including product non-conformance, consumer complaints, and manufacturing deviations. Stay current with global cosmetic regulations (FDA, EU, etc.) and ensure all products meet applicable standards for safety and labeling. Support documentation and regulatory submissions, including Safety Data Sheets (SDS) and Product Information Files (PIF). Train and mentor cross-functional teams on quality standards and best practices. Lead root cause analyses and corrective/preventive action (CAPA) initiatives. Ability to travel domestically and internationally when needed to CMs to physically audit line trials and facilities. Ability to travel domestically and internationally when needed warehouses to conduct an AQL (acceptance quality limits) on incoming product shipments. What Will Make You Stand Out: 5+ years of QA/QC experience in the beauty or personal care industry, specifically with color cosmetics and skincare or similar consumer products. Strong understanding and ability to analyze cosmetic products, manufacturing processes, and documentation. Exceptional problem-solving skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment. Proficiency with QMS software and familiarity with cosmetic testing methods (e.g., microbiological, stability, compatibility). Bachelor’s degree in Chemistry, Chemical Engineering, Cosmetic Science, or a related field. Thrive Causemetics is an Equal Opportunity Employer. Applicants must be authorized to work for any employer in the U.S. without current or future sponsorship for an immigration-related work benefit. Thrive Causemetics does not hire H-1B, F-1 CPT, OPT, or STEM OPT candidates for this role. The base pay range for this role is $85,000 - $105,000 with the following factors determining the base pay at offer: skills, qualifications, experience. This range provides the opportunity to progress as you grow and develop within a role. Additionally, this role is also eligible for an annual discretionary bonus based on company and individual performance. Thrive Causemetics provides a competitive benefits package, including but not limited to: comprehensive medical, dental and vision plans, a 401(k) plan with employer matching, various paid time off programs, employee discount/perks, life insurance, disability insurance, and employee assistance programs.

Posted 1 week ago

QA Specialist-logo
QA Specialist
Globus MedicalSan Antonio, Texas
Bone Bank Allografts, a subsidiary of Globus Medical Inc., specializes in processing and distributing high-quality bone allografts for various medical procedures, including orthopedic, dental, and reconstructive surgeries. Our commitment to excellence, supported by Globus’ renowned engineering, drives our mission to advance patient care and medical innovation through precise and efficient allograft processing and distribution. The Position Summary: The Quality Assurance Specialist works within the Quality Department to assist in compliance activities of the quality system and participate in continuous improvement activities. The primary function of the QA Specialist is to provide review and release of product records to ensure compliance to company procedure and applicable federal, state, local, and accreditation standards. Essential Functions: Perform data entry review and release ensuring entry of finished goods coincides with the Distribution software Perform secondary review of Donor Processing Records for terminally sterilized and aseptic lines Coordinate with the QA Systems Team Lead or Management to prioritize product release Perform release functions to finished goods Review test reports as part of release criteria Review technical and performance specifications Review irradiation shipment documents for acceptability Verify domestic or international requirements for product release Investigate and track status of records pending release Assist in onboarding new private label clients by verifying label requirements prior to use Assist Distribution department with the review and release of re-designated products as requested Perform Quality review of assigned records or logs and verify procedure requirements were met for approval and closure of the records Maintain error spreadsheets and create graphs/trending reports as needed Assist with performing the monthly inventory of QA product Report non-conformances and discrepancies. Participate in continuous improvement initiatives and implementations. Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Qualifications: Bachelor’s degree preferred. Experience performing file reviews and/or audits. QA or QC experience within the biotech/tissue banking industry preferred. Knowledge of GMP regulations preferred Must be knowledgeable with Microsoft Word and Excel programs. Strong typing skills, analytical skills, and problem solving techniques. Excellent communication and writing skills. Physical Demands : The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Required to sit; climb or balance; and stoop, kneel, crouch or crawl Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus Our Values : Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven. Passionate about Innovation : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate about our role in improving the lives of patients by continuously developing better solutions. Customer Focused : We listen to our customers’ needs and respond with a sense of urgency. Teamwork : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger. Driven : We pursue our mission with energy and passion. We are nimble, results-oriented, and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients. Equal Employment Opportunity : Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin, or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful. Other Duties : Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Posted 6 days ago

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QA Tech 2nd Shift
OSI CareersOakland, Iowa
Perform a variety of line audits and tests during production to ensure that product is being made within specification and that proper production and sanitary procedures are being followed. Job Responsibilities • Audit line internal temperature of cooked products; record. • Audit metal detectors with the use of standards; if detector is faulty, retain product and re-test product made since last successful test. • Perform line audits, recording speed, temperature, weights. • Perform weekly swabs of equipment/gloves and plates of air; package with instructions and send to lab. • Once per shift, gather cooked and raw product samples to send to lab with testing instructions. • Maintain and test shelf life samples; perform organoleptic duties. • Inspect code dates on bags, boxes, and cases based on product specification and production schedule. • Inspect and record cooler and freezer temperatures. • Cook samples 2-3 times per shift from all lines. • Perform hourly piece count of packed box. • Calibrate scales and thermometers daily. • Complete paperwork on employee sanitation compliance. • Follow all safety rules. • Use Personal Protective Equipment (PPE); recognize and practice Good Manufacturing Procedures (GMP). • Keep assigned area clean. • Perform other duties as assigned. Experience & Skills • 3 months of on the job training.

Posted 6 days ago

RN QA homecare and or hospice must have experience-logo
RN QA homecare and or hospice must have experience
University Home CareLivonia, Michigan
University Home Care is looking for a skilled Registered Nurse with Quality Assurance experience in the homecare and/or hospice setting to join our team in Livonia, MI. Conduct quality assurance checks on patient care plans and documentation. Ensure compliance with all regulatory requirements. Develop and implement quality improvement initiatives. Provide training to staff on quality assurance measures. Active RN license in the state of Michigan. Prior experience in Quality Assurance in homecare and/or hospice. Strong knowledge of regulatory requirements in homecare/hospice. Excellent communication and organizational skills. Competitive salary. Health and dental insurance. Paid time off. 401(k) retirement plan. University Home Care is a leading provider of homecare services in the Livonia, MI area. We are committed to providing high-quality care to our patients and ensuring a positive work environment for our employees. We have 2 positions available.One position that is full-time.Salary requires you to visit patients in the field for home care.Ann hospice in Wayne, Oakland and mccombnaughey's.The other position is for part time contractor

Posted 30+ days ago

Construction QA Supervisor (On-site) - Multiple Sites (AZ, GA, OH)-logo
Construction QA Supervisor (On-site) - Multiple Sites (AZ, GA, OH)
Decima InternationalPhoenix, Georgia
Decima International is a professional services company, providing project management and controls services to clients in the United States and the Middle East. Our mission is to become the premier professional services provider across all industry sectors we are engaged in. To accomplish this, Decima International’s founders established a simple yet powerful formula: Approach each client engagement as a partnership , create an environment that attracts the most talented professionals and allows them to flourish, and regulate growth to maintain excellence in our service standards. Decima International is a professional services company, providing project management and controls services to clients in the United States and the Middle East. Our mission is to become the premier professional services provider across all industry sectors we are engaged in. To accomplish this, Decima International’s founders established a simple yet powerful formula: Approach each client engagement as a partnership , create an environment that attracts the most talented professionals and allows them to flourish, and regulate growth to maintain excellence in our service standards. If you are interested in a long and rewarding career working with high-profile clients on some of the most challenging projects in the world, then Decima is where you belong. At Decima, you will be able to explore incredible growth and professional development opportunities. We are looking for a driven and capable Civil Structure Architecture QA Supervisor to support us with the development of multiple data center projects for one of the top technology clients in the world. This is a client-facing role that requires strong interpersonal, communication, and organizational skills, the ability to self-direct, client representation, and an emphasis on strong project management fundamentals. Must be able to manage multiple projects concurrently and across multiple regions. A strong background in data center development, design, engineering, controls, and operations requirements is a big plus. You will play an integral role in ensuring the implementation and management of the Quality Management System (QMS) in addition to the coordination, performance, and completion of all construction inspection and testing services of a project. The Civil Structure Architecture QA Supervisor is accountable for the guarantee of the work performed, as well as meeting the project’s contractual requirements set forth by the client. We are looking to bring in dedicated individuals with a passion for innovation and talent for multitasking in a fast-paced environment. We will help you grow, pursue, and fulfill what inspires you so we can make big impacts on the world, together. RESPONSIBILITIES Develop a sound knowledge of the project scope and requirements. Ensure compliance with stringent contract and owner quality requirements. Prepare comprehensive, project-specific QC plans. Review and verify material submittals for A/E and Client review. Verify delivered materials comply with approved submittals. Provide and review submittals, RFI logs, maintenance logs, and other project-related materials in a timely manner. Review and update QC punch lists and coordinate punch list completion with GC and subcontractors. Verify the implementation and operation of the quality assurance and control systems by planning and conducting internal quality audits and inspection of activities on site. Ensure implementation and continuous improvement in overall Quality Systems. Ensure that all contractual / company and local authority requirements for Quality, Health, Safety & Environment (HSE) requirements are complied with. Review, update, and verify the distribution of the Quality Management Procedure, Quality Manual, and related procedures for Infrastructure, MEP, Civil, and other subcontractors and divisions by the GC. Verify that GC implements adequate training/awareness of company personnel for Quality systems. Ensure that all non-conformance issues are promptly investigated, corrective and preventive actions are proposed/implemented, and are quickly closed out. Ensure that the contractual quality requirements of a project are fully communicated to all key personnel, so that their roles in fulfilling these requirements are fully understood. Ensure that all GC and subcontractors' quality systems and plans are acceptable to the company as applicable to the "Project Contract". Ensure that Subcontractors'/Suppliers' quality systems are implemented and effective. Ensure that the calibration of all inspection, measurement, and test equipment is conducted according to the defined schedule. Conduct reviews of the approved suppliers and subcontractors' list. Liaise with the General Contractor, Client, and Project Management team to ensure that all potential and actual quality issues are fully resolved. Establish a strong relationship with the GC and Client, and communicate with both technical and management-level personnel. Prepare PowerPoint decks and present to management on progress, findings, and recommendations. Review project plans, requirements, and specifications. Perform other related duties as required and assigned. QUALIFICATIONS Required Qualifications : 15+ years of construction quality management experience. Bachelor's degree in Civil, Structural, Architectural Engineering, or a related field. Experience with managing field engineering, inspection, and NDE related to all QA/QC functions. Ability to develop and manage non-conformance, deficiencies, and reporting programs, including root cause analysis. Experience in developing and monitoring of project QA/QC budgets. Ability to ensure that correct codes, standards, job specifications, project procedures, and federal and provincial regulations are properly identified, correctly specified in detail, and met or exceeded. Must have the ability to work within strict deadlines and under pressure while maintaining a professional demeanor. Experience working as a QA/QC Manager for large Commercial, Industrial, or Mission-Critical Facilities construction projects. An excellent understanding of construction Quality Management Systems (QMS). Experience developing various types of reports, targeting different audiences. Experience in client-facing positions. Demonstrated ability to understand technical and complicated construction programs and the ability to communicate progress to both technical and management-level personnel. Strong communication skills, including the ability to communicate with any audience clearly and accurately. Proficient in Microsoft Office programs. Preferred Qualifications: Project Management Professional (PMP) certification. Certified Construction Manager (CCM) certification. Strong background in data center development and construction. POSITION DETAILS: Primary Location: Multiple Sites (On-site) Conesville, Ohio Atlanta, Georgia Phoenix, Arizona Position: CSA QA Supervisor Position Classification: Salary-based full-time regular hours Current US work permit required. This position does not offer sponsorship for employment (e.g., H-1B visa sponsorship or transfer not offered) PRODUCTIVITY TOOLS: ​ Microsoft Office Microsoft 365 Job Type: Full-time Schedule: 8-hour shift Work Location: Multiple Sites (On-site) Conesville, Ohio Atlanta, Georgia Phoenix, Arizona Decima International is an Equal Opportunity Employer who is committed to the safety and wellbeing of all. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or breastfeeding), age, medical condition, marital or domestic partner status, sexual orientation, gender, gender identity, gender expression and transgender status, mental disability or physical disability, genetic information, military or veteran status, citizenship, low-income status or any other status or characteristic protected by applicable law. At Decima International, we offer a competitive salary package, including paid time off and performance-based bonuses. We also provide excellent medical, vision and dental insurance for our employees.

Posted 1 week ago

QA Manufacturing Specialist I/II-logo
QA Manufacturing Specialist I/II
KBI BiopharmaDurham, North Carolina
Position Summary: We are seeking a highly motivated QA Manufacturing Specialist I/II at our state-of-the-art commercial manufacturing facility in Patriot Park, Durham, NC. You will have the unique opportunity to help build our site processes and culture as we ramp up to full manufacturing capacity. We embrace KBI’s values of learning and growth, high standards, collaboration, and trust and respect to solve problems and continuously improve. As a center of excellence, our site enables real-time quality and process monitoring through paperless records with integrated automation. We are looking for a critical thinker who is comfortable tackling new challenges / unknowns and utilizing a risk-based approach. We hope you join us! Position Responsibilities: Be an on-the-floor quality partner working with the manufacturing team during operations Work with manufacturing and other groups to escalate and resolve deviations and other compliance issues Conduct QA walkthroughs Participate in safety walkthroughs Participate in process improvements Attend relevant meetings in support of manufacturing operations Review electronic batch records and logbooks Provide feedback on facility response for unplanned events Other tasks and projects as assigned Work 12-hour shifts (2-2-3 schedule, day shift) Position Qualifications: MQA Specialist I High School diploma or equivalent. Degree progression preferred. GMP / regulated industry / laboratory experience is required (approximate 1-3 years). Demonstrated ability to work in a team environment. Demonstrated ability to understand the manufacturing process. Ability to perform routine core MQA responsibilities. MQA Specialist II Associate degree / bachelor’s degree strongly preferred or appropriate years of experience (approximate 3-5 years). Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization. Demonstrated ability to represent Quality on interdepartmental meetings. Demonstrated knowledge of technical documents. Ability to support internal and external audits. Demonstrated ability to train employees on Quality subjects. Ability to track and trend department metrics Salary Ranges: MQA Specialist I: $54,000 - $74,300 MQA Specialist II: 66,966 - 92,077 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, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. 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 3 days ago

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QA Tech 1 - 1st Shift
BA Candidate GatewayIrwindale, California
Title: QA Tech I -1 st shift Department: Quality Location: Irwindale, CA Shift: 1st shift Pay rate: $20.50 an hour Reports to: QA Lead Position Summary: The QA Tech 1 is a key Quality Assurance role within the plant and supports QA team leads in safeguarding compliance with food safety and quality requirements. As a QA Tech 1 at Bonduelle Fresh Americas (“BFA”), you will embrace our vision of Giving People the Freedom to Eat HealthierTM through excellence and daily performance of essential quality assurance functions, including finished goods checks and sampling for PCT testing (Hold & Release products). What if your job had a real impact? By joining Bonduelle, the world leader in ready-to-use plant-based food, you are deciding to make a positive and sustainable impact on yourself, others and the planet. You will play an active part in our mission: "inspire the transition toward a plant-based diet to contribute to people's well being and planet health". Bonduelle is a family-run company of 14,600 people which provides over 100 countries with vegetables. Well established in the United States, our business unit includes 4 production facilities with more than 3,200 associates. We process fresh vegetables, salads and meal solutions with our own brands: Ready Pac Foods® and Bistro®. Join us at Bonduelle to start an adventure where people come first and contribute to a better future through plant-based food! Bonduelle Fresh Americas is a Certified B Corp for a better life. Bonduelle chose B Corporation because of its comprehensive and rigorous standards and its ability to measure a company’s governance as well as worker, community, and environmental impact.We aim to make a positive impact on People, Planet and Food, as seen in our global B!Pact objectives. B Corp certification validates our positive impact and tells the world we are part of a community using business as a force for good. Key Responsibilities: Ensure compliance with and maintain all GMP/PPE/Safety, HACCP & Sanitation guidelines and processes. Understand and implement requirements for product sampling and sample product following PCT sampling procedures established by the customer and corporate QA. Sample finished product for Hold & Release PCT sampling as required by customers; prepares logs and submits samples for Hold & Release tests. Conduct seal integrity tests on finished products and ensure PMOs/SMOs perform equipment adjustments as needed to ensure 100% compliance with seal integrity. Identify any and all non-conformances, document and report it to the PMO/SMO and production leads for immediate follow-up; correct abnormalities and restore functioning where needed. Clean and/or fill-up the Haug tank at the start of every shift and maintain tank water level and cleanliness throughout the shift. Log leaks, non-conformances and sample submissions in the QA database. Perform other duties as assigned. Minimum Qualifications: Strong attention to detail. Ability to read, write and speak English; comprehension of basic math. Basic computer skills and ability to multitask. Willingness and flexibility to work in a cold, wet, fast-paced, 24 hour plant environment. Ability to lift up to 50 pounds, ability to climb stairs numerous times a day. Ability to work independently and in a team environment. GED/High School Diploma. Physical Work Environment: While performing the duties of this job, this position entails use of ladders and catwalks to reach production equipment, regularly works near moving mechanical parts and is regularly exposed to extreme cold for extended periods of time. The associate frequently works in high, precarious places. The associate is occasionally exposed to wet and/or humid conditions, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. The noise level in the work environment is usually loud.

Posted 1 week ago

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QA Document Control Associate
SBM ManagementTustin, California
Description Position at SBM Management The QA Document Control Associate supports departmental operations by assisting customers with document revision and internal/external document requests. Responsibilities Support departmental operations by assisting customers with document revisions and internal/external document requests. Collaborate cross-functionally to ensure timely and effective execution of document review activities. Proficiency with the ComplianceWire electronic training system, including tasks such as assigning curricula, generating training reports, and creating or revising curricula. Issue and reconcile equipment logbooks, laboratory notebooks, and controlled documents (e.g., SOPs, forms, and logs). Maintain and organize documents within the QA archive; retrieve archived documents upon request. Uphold GMP standards and QA policies, including adherence to Good Documentation Practices (GDP). Assist in maintaining inspection readiness and provide support during regulatory and other audits. Perform additional duties as assigned by Quality Management. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job safely. Other duties, responsibilities and activities may change or be assigned at any time with or without notice. Education and/or Experience B.A. or B.S. degree (preferably in Life Science). Minimum of 1 -3 years of experience in the biopharmaceutical industry. Certificates, Licenses, Registrations May be required to have a valid driver’s license. Complete all safety and task training Knowledge, Skills, and Abilities Knowledge of CGMPs or equivalent regulations. Ability to interpret Quality standards for implementation. Skills to independently evaluate situations and propose potential solutions. Compensation: $ 26.73-35.50/hour Shifts: 9-6 pm Monday-Friday SBM Management Services, LP and its affiliates are proud to be equal opportunity workplaces. We are committed to equal employment opportunity regardless of race, sex, color, ancestry, religion, national origin, sexual orientation, citizenship, age, marital status, disability, gender identity, Veteran status, or other legally protected status. #LI-AC1

Posted 1 week ago

B
QA Tech 1 - 1st Shift (Temp Assignment)
BA Candidate GatewaySwedesboro, New Jersey
Schedule: SUN & THU OFF - 4:30AM TO 1:30PM 12 week temporary assignment Position Summary: The QA Tech 1 is a key Quality Assurance role within the plant and supports QA team leads in safeguarding compliance with food safety and quality requirements. As a QA Tech 1 at Bonduelle Fresh Americas (“BFA”), you will embrace our vision of Giving People the Freedom to Eat HealthierTM through excellence and daily performance of essential quality assurance functions, including finished goods checks and sampling for PCT testing (Hold & Release products). Groupe Bonduelle is a company that is making a positive impact Groupe Bonduelle is the world leader in ready-to-use plant-rich food. By joining our company you will have an opportunity to make a positive and sustainable impact on yourself, others and the planet. You will play an active part in our mission to inspire the transition toward a plant-rich diet to contribute to people's well-being and planet health. Groupe Bonduelle Fresh Americas is the U.S. business unit of France based Groupe Bonduelle ( BON.PA ). We are the first business unit of Groupe Bonduelle to become a Certified B Corporation. We operate three processing facilities throughout the U.S. and employ nearly 3,000 Associates who focus on producing and bringing to market fresh vegetable products, prepared salads and plant-rich meal solutions. Groupe Bonduelle is a 170 year old French family-owned company that has been at the forefront of plant based food innovations since 1853. Our ready-to-use plant-rich food products are grown on 168,000 acres by our grower partners and marketed in nearly 100 countries. The company currently employees more than 11,000 Associates globally. Join us at Bonduelle Fresh Americas for an opportunity to advance your career in a culture that places people first and makes contributing to a better future through plant-based food our top priority. Bonduelle Fresh Americas is a Certified B Corp for a better life. Bonduelle chose B Corporation because of its comprehensive and rigorous standards and its ability to measure a company’s governance as well as worker, community, and environmental impact.We aim to make a positive impact on People, Planet and Food, as seen in our global B!Pact objectives. B Corp certification validates our positive impact and tells the world we are part of a community using business as a force for good. Key Responsibilities: Ensure compliance with and maintain all GMP/PPE/Safety, HACCP & Sanitation guidelines and processes. Understand and implement requirements for product sampling and sample product following PCT sampling procedures established by the customer and corporate QA. Sample finished product for Hold & Release PCT sampling as required by customers; prepares logs and submits samples for Hold & Release tests. Conduct seal integrity tests on finished products and ensure PMOs/SMOs perform equipment adjustments as needed to ensure 100% compliance with seal integrity. Identify any and all non-conformances, document and report it to the PMO/SMO and production leads for immediate follow-up; correct abnormalities and restore functioning where needed. Clean and/or fill-up the Haug tank at the start of every shift and maintain tank water level and cleanliness throughout the shift. Log leaks, non-conformances and sample submissions in the QA database. Perform other duties as assigned. Minimum Qualifications: Strong attention to detail. Ability to read, write and speak English; comprehension of basic math. Basic computer skills and ability to multitask. Willingness and flexibility to work in a cold, wet, fast-paced, 24 hour plant environment. Ability to lift up to 50 pounds, ability to climb stairs numerous times a day. Ability to work independently and in a team environment. GED/High School Diploma. Physical Work Environment: While performing the duties of this job, this position entails use of ladders and catwalks to reach production equipment, regularly works near moving mechanical parts and is regularly exposed to extreme cold for extended periods of time. The associate frequently works in high, precarious places. The associate is occasionally exposed to wet and/or humid conditions, fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock. The noise level in the work environment is usually loud. Compensation & Benefits: We offer a competitive starting rate of $18.70/hr, commensurate with experience and qualifications. Our comprehensive benefits package includes: Health and Wellness: Medical, Dental, and Vision Insurance with multiple plan options Retirement Savings : 401(k) plan that allows employees to contribute pre-tax dollars to help plan for their financial future with a variety of investment options Paid Time Off: Generous PTO policy, including vacation days, sick leave, and paid holidays Professional Development: Tuition reimbursement program, access to online training courses, and opportunities for career advancement Additional Perks: Employee discount programs, wellness initiatives, and company-sponsored events

Posted 1 week ago

QA/QC Lab Specialist-logo
QA/QC Lab Specialist
US FertilitySan Jose, California
Luminary Life Sciences (NextGen Genetics) is illuminating the path to parenthood for individuals and families by pioneering a comprehensive suite of life science services tailored to meet the specialized needs of patients throughout every step of the reproductive health journey. Our vision is to empower patients and health care professionals by offering innovative, customer-centered solutions that provide support from pre-conception to post-birth. The QA/QC Specialist is responsible for monitoring, inspecting, and proposing measures to correct or improve all products and processes related to the collection, processing, storage, and dissemination of pre-implantation genetic tests in accordance with pertinent regulations and established quality standards. Working closely with the General Manager, the laboratory, operations, and genetics team leads, the QA/QC Specialist will be responsible for managing all licenses, certifications, and standardization programs required by Luminary Genetics to operate in accordance with established regulations and standards. Full-Time 75K-85K, Day Time Hours Essential Job Responsibilities: • Develop and implement quality control and assurance policies and procedures. • Conduct inspections, tests, and audits to ensure compliance with internal and external standards. • Monitor production processes to identify deviations or issues and recommend corrective actions. • Document quality assurance activities and create audit reports. • Investigate client/patient complaints and non-conformance issues. • Coordinate with other teams to ensure consistent quality standards are met across operations. • Review and update quality documentation, such as SOPs, work instructions, and protocols. • Support continuous improvement initiatives and process optimization. • Ensure compliance with applicable regulatory and safety standards • Train staff on quality procedures and best practices. • Ensure that all licenses and certifications are maintained accordance with established standards and regulations. • Communicate with designated regulatory bodies related to new or existing licenses and certifications. • Additional responsibilities as deemed necessary. Minimum Qualifications: • Bachelor’s degree in Quality Management, Engineering, Science, or a related field. • 2+ years of experience in quality assurance/quality control or a similar role. • Strong knowledge of quality assurance methodologies, tools, and processes. • Familiarity with laboratory regulatory standards • Excellent analytical, problem-solving, and organizational skills. • Strong communication and interpersonal abilities. • Proficiency in MS Office and quality management systems (QMS). Knowledge, Skills, and abilities: • Computer proficiency required. • Excellent verbal & written communication skills. • Ability to work as part of a multi-disciplinary team. • Excellent interpersonal skills and ability to build and maintain effective working relationships. • Flexibility and willingness to learn at all times • Excellent multi-tasking abilities Physical Requirements: The physical demands listed below are representative of the physical requirements necessary for an employee to successfully perform the essential functions of the position. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions. A request for a reasonable accommodation should be made in writing and delivered to the Talent team.

Posted 30+ days ago

F
QA Tech - Canton
Fresh MarkorporatedCanton, Ohio
The Food Safety Quality Assurance Tech (FSQA Tech) performs a wide variety of quality control testing. This includes routine observations and monitoring of receiving, manufacturing and processing activities to assure that products are manufactured and processed in compliance with internal and external customer specifications that meet applicable regulatory compliance. Minimum Requirements Two-year degree or certificate in food science or related subject preferred, High school diploma or equivalent required. One or more years previous Quality Assurance or other related experience in the Food processing facility preferred. Additional desired skills and qualifications: Knowledge of FDA GMP’s and understanding of HACCP principles Familiarity with modern food manufacturing processes and food safety systems Key Accountabilities Performs physical, analytical and microbial testing as well as sensory evaluation, as per FSQA manual and procedures. Perform process checks throughout the production, packaging, sanitation and warehousing functions of the company. Performs environmental testing using sterile technique. Coordinates with the sanitation department for execution of the environmental testing program. Communicates with FSQA management, Production, and Sanitation personnel on test results and observations made during the sanitation process. Assists the line technicians as required. Assists in the Sample Retain Program. Prepares production line FSQA Stations and calibrates equipment for processing as needed. Generates departmental reports and consolidate FSQA audit reports. Provide independent oversight of processes, verifying compliance to company standards and policies, and effectively communicating when there are deviations from standards or processes Assist in training employees on food safety, company processes and FDA Good Manufacturing Practices Maintain accurate and organized records of FSQA activities and USDA pre shipment records. Must have understanding of company and customer specifications and ensure proper documentation. Employee shall also be trained but not limited to Good Manufacturing Practices, HACCP, CCP and Safety. Attends all department and company required trainings. Food Safety and Quality Responsibilities Coordinates on sampling and testing requirements of raw materials and finished products. Conduct sampling as required. Conducts sanitation audits and performs pre-op inspection. Implements Environmental Monitoring Program. Verifies that raw materials and finished products meet set specifications. Conduct all monitoring activities to assure finished products comply with food safety and quality specifications. Reports to FSQA management on test results and if any result deviation Reports all safety, quality issues and deviations to management. Comply with all Plant, State, Federal, OSHA, EPA, FDA, USDA, HACCP, and SQF guidelines and regulations for food safety, quality and employee safety. Follow Good Manufacturing Practices requirements to ensure food safety, safe work practices. Required Skills, Knowledge or abilities: Knowledge of food safety principles Ability to understand and operate basic product testing equipment High level of organizational skills Basic math skills Attention to detail Data entry and interpretation, database maintenance. Intermediate computer skills (MS Word, Excel, etc.) Good written and verbal communication skills/fluent reading and writing skills in English Wage & Benefits Starting rate is $17.50/hr. We invite you to be part of our exciting team and rapidly growing business. Fresh Mark provides an excellent work environment and comprehensive benefits including paid vacations and holidays, educational assistance and reimbursement, health care with low premiums and deductibles, vision, 401K with company match and more. About Fresh Mark, Inc. At Fresh Mark, people come first. It’s not just a slogan, it is engrained in the fabric of who we are and what we work to achieve every day. The cornerstone of our culture is based on a foundation of taking care of all our employees on every level. As a team member here, you will be given the tools, leadership, and support to grow in your knowledge and career and as a leader yourself. Owned and made in the USA for more than 100 years, Fresh Mark’s Sugardale brand takes a personal approach to making great tasting high quality meats. For a century, we’ve been dedicated to making the best products, the best way. Made with top quality ingredients and workmanship, Sugardale supplies bacon, ham, hot dogs, sliced lunch meats, pepperoni and salami and other specialty meat items with annual sales of more than $1 billion. Fresh Mark welcomes all interested people to apply for job opportunities in our company. We pride ourselves in being a diverse company and we consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital or veteran status, disability or any legally protected status. All applicants applying for positions with Fresh Mark must accept the Employment Application Consent Form to continue their candidacy. Please click HERE for instructions. Fresh Mark is a drug free workplace. #LI-Onsite #LI-FMA

Posted 5 days ago

QA Technician (Nights)-logo
QA Technician (Nights)
Nature's BakerySalt Lake, Utah
Shift: 2-2-3 rotating schedule Nights 6am-6pm Quality Assurance Food Technician SUMMARY Monitors all quality assurance/food safety activities and makes recommendations and carries out corrections for improving Quality departmental functions. Knowledge of food quality standards and procedures is vital and good attention to detail, strong communication skills & logical thinking. Tests and inspects products at various stages of production process and compiles and evaluates statistical data to determine and maintain quality and reliability of products by performing the following duties. ESSENTIAL DUTIES AND RESPONSIBILITIES Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Perform related duties and provides support to the Quality Assurance Management. Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change. Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments. Performs tests at specified stages in the production process, and tests products for a variety of qualities such as temperature, defects, code dates, etc., records results, reviews records, and reports for accuracy and completion. Evaluates data and writes reports to validate or indicate deviations from existing standards. Recommends modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability. Completes special projects assigned, work with the project team; help to resolve problems by examining and evaluating data; selecting corrective steps. Quality analysis of incoming dry goods for production. Verification of specifications before startup and throughout production processes. Problem solving on quality issues with production and other teams. Documentation of key metrics for data analysis. Maintenance of calibration and logs of all laboratory instruments. Preparation of laboratory equipment and solutions. Direct communication with operators and production personnel. General analysis and sampling of production samples. Collection of retention samples on shiftily basis. QUALIFICATIONS: - 1 year + Experience in a Quality Assurance or food Safety role within a manufacturing facility LANGUAGE SKILLS Ability to read and interpret quality documents, safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups. MATHEMATICAL SKILLS Ability to apply mathematical operations and concepts to solving quality process-related problems.. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; sit; use hands, handle, or feel; and reach with hands and arms. The employee is occasionally required to stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, outside weather conditions, and energized equipment. The noise level in the work environment varies depending on tasks. OTHER DUTIES Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. EEO We are committed to an inclusive workplace where diversity in all its forms is championed. We are proud to be an equal opportunity workplace and we are an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. Privacy Policy Mars and its family of brands is committed to transparency and responsibility in how we handle the personal data entrusted to us by our customers and consumers. To learn more about our privacy policy please follow this link .

Posted 2 weeks ago

AI QA & Infrastructure Engineer-logo
AI QA & Infrastructure Engineer
AidalySan Francisco, California
Description About Aidaly At Aidaly, we believe family caregivers are the future of healthcare and the backbone of a thriving economy. In-home care is the fastest-growing part of healthcare, but demand is outpacing supply. We are pioneering a new model for delivering care at home by training and paying family caregivers to meet the needs of an evolving population and changing workforce. We are scaling rapidly across the United States. Join us! What You'll Do Design and execute manual and automated test plans across Aidaly’s web, mobile, and AI-driven products. Develop test cases, regression tests, and bug tracking workflows to proactively catch issues before launch. Test AI-assisted features (e.g., dynamic caregiver communications, automated documentation flows) for accuracy, relevance, and experience quality. Create and maintain testing environments that simulate real-world caregiver and ops team behaviors. Identify root causes of issues quickly and collaborate with Product and Engineering to drive resolutions. Define and track quality metrics , creating a feedback loop to improve system reliability and caregiver experience. Participate actively in sprint planning and product reviews , serving as a champion for testing, quality, and user empathy. Continuously improve QA processes by recommending and implementing new tools, frameworks, and automation methods. Requirements Who You Are 3–5 years experience in software quality assurance, QA engineering, or equivalent roles. Strong manual testing skills with a demonstrated interest in growing automated test coverage. Familiar with QA tools and frameworks such as Selenium, Cypress, Playwright, or equivalent. Deep understanding of AI/ML systems or experience testing non-deterministic outputs (bonus if you’ve worked with LLMs, AI APIs, or recommendation systems). Analytical, detail-oriented, and passionate about building seamless user experiences. Exceptional communicator — able to write clear bug reports, escalate effectively, and advocate for users internally. Comfortable in fast-paced, ambiguous startup environments where priorities evolve rapidly. Mission-driven: excited to build tools that improve lives for families and caregivers. If you're the type of person people naturally depend on for support; honest, consistent, calm under pressure, and solution-focused - WE WANT YOU! Benefits What We Offer Competitive salary + performance bonuses based on KPIs. Health, dental, and vision insurance. Paid time off and holidays. 401K (starting Q3 2025) High-autonomy, high-impact role — true domain ownership. Quarterly off-sites, trainings, and team building experiences. Opportunity to build something transformative for millions of American families.

Posted 6 days ago

QA Auditor-logo
QA Auditor
Thermo Fisher ScientificWilmington, North Carolina
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Company Name: PPD Development, L.P. Position Title: QA Auditor Location: 929 North Front Street, Wilmington, NC 28401 Summary of Duties: Audits laboratory data for GxP compliance with methods and standard operating procedures and report findings. Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings. Serves as a resource to operational departments on audit or quality assurance subject matter. Prepares and presents audit findings and/or other related information at departmental and internal operations. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Develops professional expertise, applies company policies and procedures to resolve a variety of issues, cooperating with colleagues to reach deliverables. Applies company policies and procedures to resolve routine issues. Prepares of audit findings and/or other related information and work with lab on resolving these findings. Assesses and resolves quality events. Helps prepare departmental metrics to be presented in the quality council meetings. Uses six sigma concept and knowledge to initiate and lead practical process improvement. Perform on site In-Process audit according to SOP and methods. Duties may be performed remotely. Qualifications: Bachelor’s degree in Pharmacy, Chemistry, Biology, or related field and two (2) years of experience as a Pharmacy Intern, QA Manager, Customer QA Specialist, or related role. Must have any amount of experience with: Applicable GxP and appropriate regional regulations; Support, review and revise SOPs and WPDs; Analytical documentation regarding technical areas, such as Flow Cytometry, Ligand Binding Assays, Liquid Chromatography, simple medicinal compounding, titration, or analytical testing; Quality Management System techniques including Quality Assurance (QA), Quality Control (QC), Standard Operating Procedure (SOP), Batch Record, Calibration, Validation, Documentation, Non-conformance, non-compliance, Corrective Action/Preventive Action (CAPA), Audit, Risk Assessment, and Quality Control Charts; Regulatory Compliance techniques including Regulatory Authority, Good Manufacturing Practice (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP); Auditing functions including Planning, Preparation, Conducting Quality Audits, Data Collection, Analysis and Evaluation, Reporting, Follow-up and, Closure. Experience with required skills may be gained from academic coursework or internships.

Posted 1 week ago

QA/QC Coordinator-logo
QA/QC Coordinator
E2 OpticsEagle Mountain, Utah
Join Our Team as a QA/QC Coordinator at E2 Optics! CLICK HERE to learn more! E2 Optics is a rapidly growing, award-winning, woman-owned technology integrator that specializes in low voltage solutions. We're looking for a Quality Assurance/Quality Control Coordinator to ensure that all our projects are executed in compliance with industry and customer standards. If you have a passion for quality management, experience in cabling or data center installations, and a knack for problem-solving, we want you on our team! Why Join E2 Optics? Award-Winning & Woman-Owned: Be part of a company that’s transforming the technology integration industry. Career Growth: Develop your skills with opportunities for coaching and training. Dynamic Culture: Join a team that embraces innovation, continuous improvement, and a collaborative spirit. What You'll Do: Safety First: Comply with worksite safety standards and promote safety within the team. Quality Assurance: Develop and execute the E2 Optics Quality Management System (QMS) for every project. Collaboration: Partner with internal and external stakeholders to ensure adherence to quality standards. Inspections & Reporting: Conduct quality inspections, generate data analytics, and track nonconformance reports. Continuous Improvement: Drive Lean initiatives and contribute to the success of quality-driven projects. Training & Coaching: Train internal teams on quality standards and procedures. What We're Looking For: Education: High school diploma or GED required. Experience: 2+ years of field experience with structured cabling or data center cabling installations. Experience with fiber installation and testing. Skills: Strong communication and coaching abilities. Analytical, decision-making, and problem-solving skills. Proficient in Microsoft Office (Outlook, Word, Excel). Ability to work under pressure while maintaining a positive, detail-oriented approach. Experience with technical writing and developing QA/QC procedures is a plus. WHAT WE OFFER: - Competitive pay - Opportunities for professional development and career growth. - BICSI Training Facilities - A supportive and inclusive work environment. - Health, dental, and vision insurance. - Paid time off and holidays. WORK ENVIRONMENT & PHYSICAL DEMANDS: The standard work environment for this position is an indoors business office and construction environment. Ability to use a computer and/or hand tools while sitting or standing for extended periods of time. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is regularly required to sit, talk or hear, use hands, stoop, kneel, bend, rotate, push, pull, reach with hands and arms on intermittent to regular basis daily. The employee is frequently required to stand and walk. The employee must regularly lift and/or move up to 50 pounds and frequently lift and/or move up to 25 pounds. The employee must regularly carry and climb ladders to 20 feet. The employee may be required to work in tight, confided spaces. The employee must demonstrate regular and on-time attendance. There could be a requirement of occasional travel by conventional means including aircraft, motor vehicle and the like within the region and to other locations as required. The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. DISCLAIMER: The above job definition information has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Job duties and responsibilities are subject to change based on changing business needs and conditions. An Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. Actively recruits qualified women, minorities, disabled and veterans for all positions for which they are qualified. TEXTING TERMS OF SERVICE: We may send text messages you have consented to receive. Message frequency may vary. You can cancel text messages at any time by texting "STOP". After you send "STOP", we may send you an additional text message to confirm that you have been unsubscribed. You will no longer receive text messages from that phone number, or from any member of our team. If at any time you have questions about the text messages, text "HELP". After you send "HELP" we will respond with instructions on how to use our service as well as how to unsubscribe. Message and data rates may apply.

Posted 2 weeks ago

Food Safety & QA Technologist-logo
Food Safety & QA Technologist
Smithfield FoodsCudahy, Wisconsin
If you are currently employed at Smithfield, please log into Workday and submit your application through the Jobs Hub. A great job-and a great future-awaits you at Smithfield Foods. We are an American food company with a leading position in packaged meats and fresh pork products. We’re looking for motivated people who want to join our team and grow lasting and meaningful careers with us. Apply Now! Your Opportunity As part of our FS/QA team, you would conduct routine sanitation checks, ensuring that HACCP and USDA regulations are strictly enforced. Providing technical expertise to track product from start to finish, and develop corrective actions when needed. You will be responsible for ensuring that we are able to safely deliver the best Smithfield, Eckrich, Nathan’s Famous, or any of our product brands to customers and consumers. This position is responsible for ensuring the overall quality in their assigned areas through the management of regulatory, company, and customer policies, programs and work instructions. This role is expected to conduct accurate grading and documentation of product quality against published product specifications. This position is responsible for monitoring plant programs, which may include but is not limited to: pre-op sanitation; carcass, product and room temperatures; product leakers; and GMPs. Ensures all products meet company specifications and are produced in a wholesome manner that meets Company requirements. This requires working closely with other departments on production issues/situations, product dispositions and investigations into root causes for deficiencies. Assists in managing quality programs and exercising technical expertise, including training, assessing performance and making improvements. Core Responsibilities Quality Verification Conduct all quality inspections in the area of assigned responsibility. Maintain quality objectives, prevent complaints and claims and keep quality to specifications through accurate inspections, non-compliance procedures, appropriate reporting, corrective actions and accuracy of paperwork along with sample submissions. Routine verifications and inspections include process, metal detector, cooking, and chilling type checks. Responsible for catching out of specification product by stopping the production process or removing product for rework as required. Works with other departments to implement procedure changes, based on predetermined specifications, involving raw materials and finished goods to remedy the cause of any non-compliance as quickly as possible. Ability to interpret customer and sales specifications and apply subjective quality decisions to product (ie: product appearance, color, texture, etc.). Quality Improvement Required to take action in response to poor observations by identifying and correcting deficiencies for negative micro or shelf- life data in their area of responsibility with an eye toward improvement. Utilize technical knowledge to prevent and identify the root cause of process or product failures. Continuous improvement of product quality through attention to process expected. Activities will include Quality Assurance program management, training line and other Quality Assurance employees in quality functions, daily product shows, assessing specs and updating Operations, monitoring giveaway and yields for opportunities. HACCP Programs and Food Safety Assists in development, implementation and compliance with HACCP programs that support the safe handling of food by recording and analyzing critical control point records that track product through the plant ensuring the safety of food products at all times. Properly review and scrutinize all aspects of the food safety system and meat production processes. USDA Regulatory Requirements Ensure the USDA regulatory requirements for Food Safety are met. Assist with revisions and update food safety programs and procedures including the annual reassessment of all programs. Sanitation Checks Conducts pre-operation sanitation checks to ensure all pre-operation sanitation has been done correctly. Determines need for re-sampling of equipment and communicates information to sanitation and plant personnel. Conducts follow up to ensure the sampling was properly completed. Food Safety Deficiencies Communicates findings regarding food safety deficiencies to Plant Food Safety Manager and provides feedback and recommendations. Assists with the training to plant employees regarding food safety deficiencies and corrective actions as needed. Absence In the absence of key personnel, the employee’s supervisor or qualified designee (one that has been trained in the key employee's duties) is responsible to complete or delegate the completion of all required tasks and responsibilities. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. May perform other duties as assigned. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions. High school diploma or general education degree (GED), required For internal candidates with 4+ years of experience with the company, the Company has the discretion to waive educational requirements. Associate’s degree, preferred Ability to create, revise and interpret technical documents such as quality specifications, safety rules, operating and maintenance instructions, and procedure manuals Knowledge and understanding of quality assurance principles, food science and meat processing A high level of technical expertise, ownership and practical knowledge of all Quality Assurance and regulatory programs Ability to write routine reports and correspondence - Ability to use exposure monitoring equipment, interpret and communicate results Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form Ability to work on the internet, Spreadsheet, Presentation and Word Processing software Comprehensive experience and understanding of USDA Rules and Regulations Ability to uphold regulatory, company, and customer standards Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community Strong written and verbal communication skills. Strong decision making and problem-solving skills. Must have the ability to complete required applicable forms in English, which requires the ability to read and write in English. Ability to work well with others in fast paced, dynamic environment. Ability to be respectful, approachable and team oriented while building strong working relationships and a positive work environment. Work Environment & Physical Demands The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Office and plant setting. The plant environment will include wet or humid conditions (non-weather related), extreme cold and heat (non-weather related), working near moving mechanical parts, exposure to fumes or airborne particles, and chemicals. Noise level in the work environment is usually moderate but can be loud when in the production area. Occasionally lift and/or move up to 50 pounds. Specific vision includes close vision, distance vision, and ability to adjust focus. Exposed to temperatures ranging from 30 - 80 degrees, working in warm and cold area simultaneously. Frequently required to stand for prolonged times; walk; use hands to handle, or feel; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear. 

Relocation Package Available

No

 EEO Information Smithfield is an equal opportunity employer committed to workplace diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, age, gender identity, protected veterans status, status as a disabled individual or any other protected group status or non-job characteristic as directed by law. If you are an individual with a disability and would like to request a reasonable accommodation for any part of the employment selection process, please call us at 757-357-1595.

Posted 1 day ago

Senior QA Specialist - Analytical Support-logo
Senior QA Specialist - Analytical Support
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: This individual is responsible for the compliance review of Biopharmaceutical GMP data. This includes the review and approval of in-process, release, and stability test data. Provides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification, method transfers, method validations, creation and revision of test methods, specifications, stability studies, laboratory investigations and laboratory deviations. The Senior QA Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. Collaborates with clients, laboratories, manufacturing, QA batch disposition and other internal stakeholders as needed to achieve site, operational and department specific goals. Cultivates and maintains Quality culture. Responsibilities: Performs timely review of test data for in process, release, and stability samples. Assures activities comply with required procedures, cGLP, and cGMP requirements. Responsible for the review and approval of method verification, transfer, qualification, and validation related to the testing of in-process, release, and stability testing. Provides QA support for Deviations, CAPAs, Laboratory Investigations, Change Controls and Projects related to laboratory processes, instruments, specifications, methods and SOPs. Attends relevant operational meetings in support of Manufacturing operation, analysis and disposition activities. Supports client audits and regulatory inspections as required. Other activities as assigned by Management. Requirements: Bachelor’s degree and 8+ years’ experience or Master’s degree and 4+ years’ experience in a QA, QC or cGMP environment in Biopharmaceuticals or equivalent. Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills. Strong understanding of FDA, EU and cGMP regulations is required. Experience in Quality Control and Quality Systems is beneficial. Salary Range: $101,000 - $138,600 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. 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 1 week ago

QA/QC Engineer-logo
QA/QC Engineer
Rosendin ElectricAbilene, Texas
Whether you’re a recent grad or a seasoned professional, you can experience meaningful career growth at Rosendin. Enjoy a true sense of ownership as you work with a proven industry leader on some of the most exciting and high-profile projects in the nation. We offer a wide range of job opportunities, competitive compensation, full benefits, an Employee Stock Ownership Plan and more. Why Rosendin? Committed. Innovative. Engaged. If you’re looking to take your career to the next level and work with some of the best and brightest in the industry, we want to hear from you. Since our founding over 100+ years ago, Rosendin has been driven to positively impact the communities where we live and work. We are an organization built on integrity and we have a culture that empowers people, embraces diversity, and inspires everyone to do their best. As one of the largest EMPLOYEE-OWNED electrical contractors in the United States, you will have the unique benefit of being a shareholder at a company that is experiencing tremendous growth and success. When our people succeed and fuel our success, we reward them. We'd love to have you as a shareholder! YOUR NEXT OPPORTUNITY: The QA/QC Engineer (Renewables) is responsible for managing and implementing the Rosendin, and/or project specific, QA/QC program. WHAT YOU’LL DO: Review all installation methods for conformance to the contract documents. Ensure all materials and equipment delivered to the site conform to the contract documents. Conduct pre-installation meetings with the safety manager and foreman prior to proceeding with new phases of installation to ensure safety and compliance with the contract documents. Make regular site inspections, provide detailed reports noting any deficiencies in the installation and make follow up inspections to ensure corrective work is done. Make all inspection requests and walk with inspector to ensure that all inspections are complete, approved and documented. Be responsible for all QA/QC documentation and record keeping including final QA/QC control submittals. The duties and responsibilities are intended to describe the general nature and scope of work being performed by this position. This is not a complete listing and other duties will be assigned based on the positions role within the business unit. WHAT YOU’LL NEED TO BE SUCCESSFUL: Proficient in using a computer and Microsoft Office (Outlook, Word, Excel, etc.); Oracle preferred Ability to prioritize and manage multiple tasks, changing priorities as necessary Ability to work under time pressure and adapt to changing requirements with a positive attitude Effective oral and written communication skills as required for the position Ability to be self-motivated, proactive and an effective team player Ability to interact effectively and professionally with all levels of employees, both management and staff alike, vendors, clients, and others WHAT YOU BRING TO US: Bachelor’s degree in Construction Management or related field Can be a combination of education, training and relevant experience TRAVEL: 100 % WORKING CONDITIONS: General work environment – sitting for long periods, standing, walking, typing, carrying, pushing, bending. Work is conducted primarily indoors with varying environmental conditions such as fluorescent lighting and air conditioning Noise level is usually low to medium; it can be loud on the jobsite. We fully comply with the ADA and applicable state law, including considering reasonable accommodation measures that may enable qualified disabled applicants and employees to perform essential functions. Occasional lifting of up to 40 lbs. Rosendin is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer. Employment decisions are considered regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, pregnancy, age (over 40), or any other categories protected by applicable federal, state, or local law. YOU Matter – Our Benefits ESOP – Employee Stock Ownership 401K Annual bonus program based upon performance, profitability, and achievement 17 PTO days per year plus 10 paid holidays Medical, Dental, Vision Insurance Term Life, AD&D Insurance, and Voluntary Life Insurance Disability Income Protection Insurance Pre-tax Flexible Spending Plans (Health and Dependent Care) Charitable Giving Match with our Rosendin Foundation Our success is rooted in our people. We all come together around long-term vision and a sense of shared ownership. As a group, we do whatever it takes to ensure the success of our business…and your career. Rosendin Electric is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer. Employment decisions are considered regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Posted 30+ days ago

Genentech logo
QA Specialist/Senior QA Specialist, Manufacturing Quality
GenentechHillsboro, Oregon

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Job Description

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche’s commercial portfolio & pipeline products.  The Operations organization at HTO is divided into 2 production streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.


 

The Opportunity:

In this exciting role, you will provide direct manufacturing quality oversight at HTO. As part of a dynamic and inclusive team, you will partner with manufacturing and other stakeholders at the site and in the network to supply patients. You will apply knowledge of aseptic drug product manufacturing processes, of health authority expectations and industry standards. You will act as a mentor and coach for the organization.

  • You will act as key quality contact to manufacturing for discrepancy management, line support and batch review for commercial and launch products. 

  • You will provide quality oversight related to operational activities, procedures and processes. You will ensure that investigations are accurate, include appropriate corrective actions, and follow regulations, industry guidelines and company standards.

  • You will apply your in-depth practical and conceptual knowledge in the manufacturing and quality functional areas at the site and within the company network.

  • You will support internal cGMP audits and Health Authority inspections as a technical resource and quality subject matter expert.

  • You will develop new approaches to complex problems. You will lead coordination and issue resolution across HTO Manufacturing Operations, support groups and/or projects (e.g. Operations Teams) as needed.

  • You will be responsible for setting the strategic direction and framework of one or multiple programs within HTO Quality in the areas of process development, process improvement, quality and compliance. You will own the deliverables within the established programs and lead teams in their execution in line with the site strategy. 

  • You will be accountable for managing key operational support activities related to product transfers and new equipment/process start-up (manufacturing readiness and process design, documents, engineering runs, equipment set up, etc.).

Who you are:

  • You hold a Bachelor’s degree (preferably within the Life Sciences or Engineering)

  • For a QA Specialist, you have at least 5  years of experience in the pharmaceutical industry.  For a Senior QA Specialist, you have at least 8 years of experience in the pharmaceutical industry.   

  • You are a strong problem-solver and have the demonstrated ability to troubleshoot and resolve process-related issues, ensuring efficient operations and regulatory compliance.

  • You possess a deep understanding of safety, quality systems, and quality assurance concepts including the application of current Good Manufacturing Practices (cGMPs) in aseptic processing and production.

  • You have a solid understanding of aseptic processing principles, regulations, and industry guidelines relevant to biologics processing, including knowledge of quality assurance principles, quality systems, microbiology, and sterility assurance.

  • Your interactions exhibit tactful and effective communication skills as they often involve complex and sensitive information.

  • You are able to gown into production space. 

Preferred:

  • You have a Master’s degree (preferably within the Life Sciences or Engineering) 

  • You have experience in nPFS (nested pre-filled syringe) filling

  • You have experience in medical devices

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $75,000 - $139,400 for the QA Specialist level and $91,100 - $169,100 for the Senior QA Specialist. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.  This position also qualifies for the benefits detailed at the link provided below.

Link to Benefits

This position is eligible for relocation benefits. It is not eligible for full time remote work arrangements.

#gnehtoquality

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

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