Title: GMP Quality Assurance Specialist – Raw Materials
Location: Greater Boston Area, MA (On-site, 5 days/week)
Employment Type: Contract (12+ months)
Status: Accepting Candidates
About the Role
Join a leading biotechnology environment supporting GMP quality operations focused on raw materials and consumables. This role plays a key part in ensuring compliance, documentation accuracy, and material release processes within a regulated manufacturing setting.
Key Responsibilities
- Provide QA oversight for incoming raw materials and consumables used in internal manufacturing
- Review GMP documentation associated with incoming materials and consumables
- Perform final review of executed GMP documentation to determine material acceptability in accordance with SOPs
- Ensure all required documentation is complete and compliant prior to release of materials
- Support day-to-day quality operations related to material management
- Manage supplier-related quality issues, including SCARs (Supplier Corrective Action Reports)
Qualifications
- Bachelor’s degree in a scientific or allied health field (required)
- Minimum 3+ years of relevant GMP quality experience
- Strong experience with raw material release and material management processes
- Knowledge of GMP quality operations and documentation review
- Experience handling supplier quality issues (e.g., SCARs)
- Detail-oriented with strong documentation and compliance focus (non-lab, documentation-based role)
Compensation (MA Pay Transparency):
- Estimated hourly range: $50–$60/hr (W-2)
- Final rate within this range will be based on skills, experience, and interview results
