QA Specialist I - GMP Manufacturing & Cleanroom
Vericel® Corporation
Vericel Corporation, a leader in advanced cell therapies, seeks a QA-focused professional for day-to-day batch record review, labeling, archiving, and final product inspection in our Burlington, MA facility. You'll gown into ISO 7 clean rooms and support release activities on a Tuesday–Saturday or Sunday–Thursday schedule, with some training/monthly relocation to Cambridge. Strong GMP knowledge and Excel skills are required. #J-18808-Ljbffr Vericel® Corporation
- Anika in Bedford, MA is seeking a Senior Quality Assurance Specialist to provide QA oversight across CMC development, manufacturing, and supply chain. You will serve as a subject matter expert in GMP quality systems, regulatory readiness, and continuous improvement of...Suggested
- What You’ll DoThe Senior Quality Assurance Specialist provides quality assurance oversight... ...Quality Control, Analytical Development, manufacturing, and supply chain activities, ensuring compliance... ...you serve as a subject matter expert in GMP quality systems, CMC quality oversight,...SuggestedFull timeContract workImmediate start
$110k - $120k
...Our goal is to discover, develop, manufacture, and commercialize... ...management. This role is part of a small QA team with opportunities for cross... ...Your Impact: As the Senior QA Specialist, you will: Maintain Quality oversight of GMP operations including batch record...SuggestedFlexible hours- ...Therapeutix, Inc., headquartered in Bedford, MA, seeks a Senior QA Associate to provide QA oversight across drug product production,... ...transfer to commercialization. You’ll ensure QC activities meet GMP/GLP standards and regulatory expectations, focusing on data integrity...Suggested
$100k - $115k
...provide process development, produce GMP viral vectors, and provide cell... ...of biologics/gene therapy manufacturing operations, the Senior Quality Assurance Specialist champions collaborative day to day... ...batch disposition activities. QA support of drug product aseptic...SuggestedLive inVisa sponsorshipShift work$80k - $95k
...provide process development, produce GMP viral vectors, and provide cell... ...support of biologics/gene therapy manufacturing operations, the Quality Assurance Specialist II engages in collaborative day to... ...batch disposition activities. QA support of drug product aseptic fill...Live inVisa sponsorshipMonday to FridayAfternoon shift- Nova Biomedical is seeking a QA Specialist to strengthen our Quality Management System and ensure regulatory compliance across our operations... ...continuous improvement with cross-functional teams across Manufacturing, Engineering, Regulatory Affairs and Quality Control. Ideal...
$77k - $86k
...clinical markets. Job Summary: The Quality Assurance (QA) Specialist supports the effectiveness, compliance, and continual... ...templates Prepare and review Engineering Change Orders (ECOs), Manufacturing Variances (MVs), and other controlled changes Support...Hourly payWork at officeFlexible hours- ...The Quality Assurance Specialist will actively contribute to the implementation... ...Systems Manual and conduct GMP compliance audits as directed. The QA Specialist will have oversight of... ...including work performed by Contract Manufacturing Organizations (CMOs). Provide assistance...Contract work
- ...Sr. Quality Assurance Specialist A Few Words About Us Integrated Resources, Inc is a premier... ...Professional will work in the Internal QA team of company's Human Genetic... ...Department. This unit oversees internal manufacturing on behalf of company. Support of Commercial...
$28.85 - $34 per hour
...able to gown into classified manufacturing ISO 7 clean room areas, to conduct... ...product within an ISO 7 cleanroom. Support day to day operations... .... Support projects as a QA resource. Identifies deficiencies... .... Basic working knowledge of GMP regulations. Preferred Qualifications...Hourly payFor contractorsWork at officeMonday to FridayWeekend work$66.8k - $124k
We are seeking an experienced Senior QA Specialist, RLT Manufacturing Operations to join Mariana’s Quality Assurance organization, advancing personalized... .... The Senior QA Specialist for Radioligand GMP Manufacturing Operations plays a critical role in ensuring...- PCI Pharma Services is seeking a QA Specialist II to ensure product quality and compliance across... ...and investigations to uphold GMP standards. The position involves collaboration... ...strong QA background in pharmaceutical manufacturing is required. #J-18808-Ljbffr...
- ...pioneer and shape the future of PCI. The QA Specialist II will work with other departments to... ...providing QA expertise and guidance to the manufacture of both clinical and commercial products... ...in support of batch release and GMP compliance Provide direction for complex...Weekend work
$65k - $80k
...Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research,... ...System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other... ...Essential Functions: The QS Specialist I will be expected to support all activities...Work at officeWorldwideShift work- ...Quality Assurance Professional will work in the US External QA team responsible for Contract Manufacturing (CMO) and Contract Test Laboratories (CTL) oversight... ...CTL metrics, data, and deliverables. Experience with GMP programs in cGMP biotech and/or pharmaceutical...Contract workFlexible hours
$20 - $25 per hour
...Now Hiring: Quality Assurance Specialist Lowell, MA $20.00–$25.00 per hour (DOE) Full-Time | Day Shift | 6:00 AM – 4:00 PM Help... ...safety? Are you detail-oriented and enjoy working in a fast-paced manufacturing environment? PGI Foods is looking for a Quality Assurance...Hourly payFull timeImmediate startDay shift$85k - $105k
Quality Assurance Specialist II, Device Engineering Location: Woburn, MA (relocating to a new facility... ...and test method validation activities Review GMP documentation, batch records, protocols, reports, and manufacturing records Support supplier quality programs, audits...Relocation- ...Quality Assurance Specialist Location: Lexington, MA Duration: 3 years Contract This is HYBRID job Responsibilities include but... .... Plan, design, deploy, maintain and troubleshoot related to QA tools like Tricentis TOSCA and Impact Analysis/Live Compare tool...Contract workApprenticeshipLocal area
- ...QA Specialist Perform the QA review/approval of analytical documentation: Analytical method validation protocols and reports for in... ...reference standard/critical reagent qualifications Collaborate with manufacturing support functions to develop the methods and acceptance...
- ...and leverage their skills in an innovative way. Quality Assurance Specialist Dash Bio is seeking a detail‑oriented and motivated Quality... ...Specialist will work closely with the Director, Site Quality and senior QA staff to carry out routine site quality, lab systems, and study...
- DescriptionUnder the direction of the Patient Access Manager, the Training & QA Specialist is responsible for the orientation and training of the new employees and ongoing training of staff on information systems, customer service skills, compliance topics, and policies...Work at officeShift work
$220k - $275k
...applications, and advanced testing enabled by multi-function, multi-modal capabilities. STR is seeking a Principal Quality Assurance (QA) Specialist to work with Leadership and across STR organizations to develop and implement procedures and infrastructure related to QA as...Full timePart timeLocal areaNight shift- ...QA Documentation Associate A Few Words About Us Integrated Resources, Inc is a premier... ...and regulations, review/approval of GMP procedures, protocols and reports, support... ...compliance audits. Interfacing with key Quality, manufacturing, and PO&T customers. The Associate I will...
- Werfen is seeking a QS Specialist I to support the Quality Management System, ensuring GMP compliance and FDA/ISO standards adherence. You will assist CAPA activities, audits, and management reviews under supervision, contributing to quality improvements across the organization...
- ...accurate and timely production and shipment of products. Perfect opportunity for anyone to start or make a career switch into the manufacturing shipping and logistics industry. No previous experience required. All training is provided on-the-job. Weekly Pay with...Weekly payImmediate startShift work
- Entegris is seeking Manufacturing Technicians for our facilities in Billerica, MA and Bedford, MA. The role involves operating and maintaining UPE Membrane equipment, executing processes from extrusion to packaging, and ensuring compliance with quality standards. You will...
- Werfen is seeking a QS Specialist I to support planning, coordination, and continuous improvement of the Quality Management System in compliance with GMP, FDA, and ISO standards. The role focuses on assisting in CAPA, audits, supplier audits, management reviews, and documentation...
- ...Quality Assurance Specialist Ready to put your skills as a reliable, detail-oriented professional to use and grow in your career? We're hiring quality assurance specialists and technicians right now. What's in it for you? A consistent schedule. Opportunities to grow...Immediate start
- ...opportunities. Job Summary The Quality Specialist will have two primary responsibilities.... ...concise procedures with input from quality / manufacturing engineers Process data and transform... ...with industry regulations (e.g., ISO, GMP) related to documentation Familiarity with...Minimum wagePermanent employmentWork experience placementWork at officeLocal areaShift work
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