- Quincy, Massachusetts, United States
- On-site
- Full-time · Associate
- $65K–$72K per year
- 2+ years
Review batch records, manufacturing documentation, and supporting quality records to ensure GMP compliance and readiness for product release.
Compensation
For this role, the anticipated base pay range is $65,000 - $72,000 annually.
Responsibilities
- Perform issuance, review, approval, and control of GMP-quality documentation, batch records, and associated records
- Conduct thorough document reviews to ensure compliance with GMP, GDP, internal procedures, and regulatory requirements
- Support product release and disposition activities through review of manufacturing, testing, and quality documentation
- Collaborate with Manufacturing, Operations, Collection Centers, and external partners to resolve documentation issues and quality concerns
- Support the maintenance and continuous improvement of the Quality Management System (QMS) in alignment with applicable regulatory standards
Requirements
- Bachelor’s degree within life sciences or a related scientific discipline