Quality Assurance Specialist

4 days ago


Cambridge, Massachusetts, United States Voyager Therapeutics, Inc. Full time
Job Title: Quality Assurance Specialist

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.
Requirements:
  • 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.
Additional Experience Desired:
  • Biological Drug Substance production.
  • Production of Injectable Products.
  • Performance of GMP compliance audits.
  • Oversight and interactions with CMOs.


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