Quality Assurance Specialist
4 days ago
Voyager Therapeutics, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our products.
Key Responsibilities:- Develop and maintain the Quality Systems Manual, ensuring compliance with regulatory requirements.
- Conduct GMP compliance audits of Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs).
- Review and approve Policies and SOPs authored by other functional areas.
- Primary reviewer of CMO Master Batch Records (MBRs) and executed batch records.
- Assist Clinical Operations in the development of Clinical Protocols, Investigator Brochures, and other clinical documents.
- Participate in investigations of deviations, ensuring the development of Corrective Actions and Preventative Actions (CAPA).
- Review and approve Technical Transfer Documents and CMO Protocols and Reports.
- Conduct and support GMP audits of suppliers and CMOs.
- Participate in the company internal compliance audit program.
- Represent Quality in various cross-functional Program Teams.
- BS in chemistry, pharmacy, biochemistry, or related discipline.
- Minimum 7 years QA GMP experience in biotech/pharmaceutical environment required.
- Demonstrated knowledge and understanding of quality compliance principles with specific focus on GMPs.
- Biological Drug Substance production.
- Production of Injectable Products.
- Performance of GMP compliance audits.
- Oversight and interactions with CMOs.
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Quality Assurance Specialist
3 weeks ago
Cambridge, Massachusetts, United States Voyager Therapeutics, Inc. Full timeJob Title: Quality Assurance SpecialistVoyager Therapeutics, Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the quality and compliance of our products.Key Responsibilities:Develop and maintain the Quality Systems Manual, ensuring it...
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Senior Quality Assurance Specialist
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Cambridge, Massachusetts, United States Proclinical Staffing Full timeJob Title: Incoming Materials, Senior QA SpecialistProclinical is seeking an experienced Incoming Materials, Senior QA Specialist to join our team in Cambridge, MA.Job Summary:The Incoming Materials, Senior QA Specialist will play a critical role in ensuring the quality and compliance of materials procured by our organization. This position requires a strong...
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Quality Assurance Specialist
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Quality Assurance Supervisor
2 weeks ago
Cambridge, Massachusetts, United States Vericel Corporation Full timeJob Title: Quality Assurance SupervisorVericel Corporation, a leading biotechnology company, is seeking a highly skilled Quality Assurance Supervisor to join our team in Cambridge, MA. As a key member of our Quality Operations department, you will be responsible for leading a team of QA Specialists and ensuring the highest standards of quality in our...
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Incoming Material Quality Assurance Specialist
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Cambridge, Massachusetts, United States Alphanumeric Systems Inc. Full timeJob Title: Incoming Material Quality Assurance SpecialistAlphanumeric Systems Inc. is seeking a highly skilled Incoming Material Quality Assurance Specialist to join our team in Cambridge, MA. As a key member of our quality assurance team, you will play a critical role in ensuring the quality and compliance of materials procured by our...
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GCP Quality Assurance Specialist
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Quality Assurance Specialist
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Quality Assurance Specialist
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Senior Registered Nurse
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Quality Assurance Supervisor
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Cambridge, Massachusetts, United States Vericel Corporation Full timeJob Title: Quality Assurance SupervisorThis is an exciting opportunity to join Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, as a Quality Assurance Supervisor. In this role, you will be responsible for leading a team of QA Specialists and overseeing the day-to-day Quality Operations activities.Key...
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Senior Registered Nurse
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Senior Registered Nurse
3 weeks ago
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Senior Registered Nurse
4 weeks ago
Cambridge, Massachusetts, United States Mass General Brigham Full timeJob Title: Senior Registered Nurse - Quality Assurance SpecialistMass General Brigham is seeking a highly skilled and experienced Registered Nurse to join our team as a Senior Registered Nurse - Quality Assurance Specialist. This role will be responsible for coordinating clinical quality assurance activities, including the development and review of training...
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Quality Assurance Supervisor
4 weeks ago
Cambridge, Massachusetts, United States Vericel Corporation Full timeJob Title: Quality Assurance SupervisorVericel Corporation, a leading biotech company, is seeking a highly skilled Quality Assurance Supervisor to join our team in Cambridge, MA. As a key member of our Quality Operations department, you will be responsible for leading a team of QA Specialists and ensuring the highest quality standards in our manufacturing...
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Quality Assurance Specialist
3 weeks ago
Cambridge, Massachusetts, United States The Fountain Group Full timeQuality Control Laboratory TechnicianWe are seeking a highly skilled Quality Control Laboratory Technician to join our team at The Fountain Group. As a key member of our quality control team, you will be responsible for ensuring the highest standards of quality in our laboratory operations.Key Responsibilities:Perform routine testing and assay control...
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GCP Quality Assurance Specialist
4 weeks ago
Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob OverviewStratacuity is seeking a highly skilled GCP Quality Assurance Specialist to oversee compliance and quality processes for clinical trials. As a key member of our team, you will manage relationships with CROs, Investigator Sites, and stakeholders to ensure seamless project execution.Key ResponsibilitiesDevelop and maintain GCP Quality Systems and...
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Incoming Material Quality Assurance Specialist
4 weeks ago
Cambridge, Massachusetts, United States Randstad Life Sciences US Full timeJob Title: Incoming Material SeniorJoin our team at Randstad Life Sciences US as an Incoming Material Senior, where you will play a critical role in ensuring the quality and compliance of materials procured by our organization.About the Role:As an Incoming Material Senior, you will be responsible for evaluating incoming materials to ensure they meet the...
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Quality Assurance Specialist
4 days ago
Cambridge, Massachusetts, United States Integrated Resources, Inc ( IRI ) Full timeJob Title: Quality Document Control SpecialistJob Type: 6 months on W2 ContractLocation: Cambridge, MAJob Description:Duties:We are seeking a highly organized and detail-oriented Quality Document Control Specialist to join our team at Integrated Resources, Inc. (IRI). As a key member of our quality team, you will be responsible for:• Processing, sorting,...
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Senior Quality Assurance Specialist
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Cambridge, Massachusetts, United States PSG Global Solutions Careers Full timeJob Title: Senior Quality Control AssociateAt PSG Global Solutions Careers, we're seeking a highly skilled Senior Quality Control Associate to join our team. As a key member of our quality assurance department, you will play a critical role in ensuring the quality and compliance of our raw materials.About the Role:We're looking for a seasoned professional...
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Quality Assurance Specialist
3 weeks ago
Cambridge, Massachusetts, United States Integrated Resources, Inc ( IRI ) Full timeJob SummaryWe are seeking a highly skilled Quality Systems and Compliance Specialist to join our team at Integrated Resources, Inc (IRI). This role will support Quality Systems and Compliance functions in managing product complaints, regulatory inspection preparation, and document control.Key ResponsibilitiesManage product complaints, including intake,...