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
$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- 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
- ...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...SuggestedContract work
$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... ...Basic working knowledge of GMP regulations. Preferred Qualifications...SuggestedHourly payFor contractorsWork at officeMonday to FridayWeekend work- ...Job Description• The Quality Assurance Professional will work in the Internal QA team of company's Human Genetic Therapies Quality Assurance Department.• This unit oversees internal manufacturing on behalf of company.• Support of Commercial QA Compliance: Deviation Review...Suggested
$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
$81.15k - $101.96k
...Taichung. Position Overview: The Quality Assurance Specialist reports to the senior manager of QA and will play a key role in managing the product... ...applicable FDA regulations, ICH guidelines, and relevant GCP, GMP, and GDP expectations. Working knowledge of DSCSA...Flexible hoursShift workAfternoon shift- ...6-01797 Summary: The Operational Area Senior Quality Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials... ...Experience providing QA support and oversight of GMP manufacturing operation Experience successfully...Work at office
- ...Job Description Job Description CMC QA ASSOCIATE Location; Bedford, MA JOB... ...cross functional team (i.e., PD, MSAT, CMC, Manufacturing, Regulatory Affairs etc.) to confirm the... ...and at external partners. Ensure GMP processes are implemented in the Quality...Contract workInterim roleLocal area
- PharmaEssentia USA in Burlington, MA is seeking a Quality Assurance Specialist to manage the product quality system, review batch records, deviations, CAPA, recalls, and DSCSA compliance. The role ensures proper documentation, timely responses, and cross-functional support...
$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$110k - $120k
...Description About Lexington Medical Lexington Medical designs and manufactures AEON™ surgical stapling technology at our headquarters in... ...behind it. About the Role As a Senior Quality Systems Specialist at Lexington Medical, you will be the hands-on owner of our...$85.4k - $158.6k
...experienced Senior Quality Assurance Specialist, to join Mariana’s Quality... .... The Senior QA Specialist plays a critical role... ...radiopharmaceutical products are manufactured, tested, and released in full... ...(SME) in radiopharmaceutical GMP requirements, aseptic operations...- ...Lancesoft Job Details: Title : Quality Assurance Specialist Location : Lexington, MA Duration: 3 years Contract... ...• 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...
$72k - $91.5k
...Quality Control Specialist Lexington, MA Kiniksa Pharmaceuticals is a commercial-stage... ..., the Stability Coordinator manages the GMP stability programs, supporting trending... ...Analytical Development, Quality Control, Manufacturing, CMC, Validation, and Quality Systems....Contract workWork at office$20 - $25 per hour
...Description Overview Now Hiring: Quality Assurance Specialist – Food Manufacturing ???? Lowell, MA ???? $20.00–$25.00/hour, depending on experience... ...quality, and manufacturing programs Follow established GMP, sanitation, safety, and quality procedures What We're...Full timeImmediate startDay shift$63.65k - $92.57k
...these areas. Assist with the development and delivery of regular reports on performance, trends, and other actionable insights to the QA, Training, and Operations Leadership teams. Document evaluations utilizing departmental quality monitoring templates, established...Remote workShift work- ...Kinikska Pharmaceuticals seeks a Quality Control Specialist to coordinate GMP stability programs in Lexington, MA. The role involves managing stability data tracking, collaborating with contract laboratories, reviewing laboratory results, and supporting shelf-life determinations...Contract work
- ...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... ...audits. Interfacing with key Quality, manufacturing, and PO&T customers. The Associate I will...
$111k - $123k
...Department: Quality AssuranceReports to: VP, Quality AssuranceLocation: Cambridge, MAPosition SummaryThe Senior Quality Engineering Specialist provides hands-on operational support for Prime Medicine’s GxP software, equipment, calibration, preventive maintenance, and...Full timeTemporary workRemote work$80k - $140k
...and strengthen the team’s ability to test intelligent features with speed, rigor, and confidence. This role is ideal for a mid-level QA professional who combines strong software testing fundamentals with hands-on experience applying AI in the test process and testing AI...Full timeTemporary workFlexible hours- ...ApplicationsEmail: ****@*****.*** PR Range: 103-129/hr DOESeeking an experienced Principal Clinical Quality Assurance Specialist to provide expert guidance and hands-on support for Good Clinical Practice (GCP) quality across the company’s biologics clinical...Contract work
- ...Senior Quality Engineering Specialist at a gene-editing biotech company provides operational support for GxP-regulated software, equipment, and vendor oversight. The role executes qualification activities, maintains compliance records, and conducts risk-based assessments...
- Position Summary As PASCALL scales its FDA-cleared EEG platform and expands the quality function beyond a single QA resource, we need a Quality Officer to own day-to-day execution of the Quality Management System (QMS), keeping documentation, audits, and change control...Remote workWorldwide
$88.43k - $125k
...Quality Control SpecialistAs a Quality Control Specialist at MKS, you will partner with cross-functional teams, including Engineering... ...QualitySupporting and maintaining calibration systemsWorking closely with Manufacturing (Tech Ops) to support daily production needsParticipating in...Work at officeVisa sponsorshipWork visaRelocation package$88.43k - $125k
...R21874 A Day in Your Life at MKS: As a Quality Control Specialist at MKS, you will partner with cross-functional teams, including... ...and maintaining calibration systems Working closely with Manufacturing (Tech Ops) to support daily production needs Participating...Permanent employmentFull timeWork at officeVisa sponsorshipWork visaRelocation package$84.3k - $126.5k
...Role:MilliporeSigma in Burlington, MA is hiring a Service Quality Specialist. This position is part of the North America (NA) Lab Water... ...Management Systems (QMS) experience1+ years of Quality Assurance (QA) experiencePreferred Qualifications:Bachelor's degree in a Science...Local area- ...our people, and our pigs. POSITION SUMMARY The Senior Quality Systems Specialist will be supporting the QA team to implement and manage Quality Systems supporting GMP Manufacturing and Testing across all eGenesis locations. This position reports to the Associate...
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