quality assurance specialist - gmp - hybrid
Randstad
- Norwood, MA
- $55.00-56.00 per hour
- Temporary
- Full-time
- 3+ years of experience in a GMP Manufacturing environment, focused on Quality Assurance
- Bachelor’s degree in a science related field
- Experience with Raw Material Batch record review (DNA and lipids) preferred
shift: First
work hours: 8 AM - 4 PM
education: BachelorsResponsibilities
- Conduct thorough review of Master Batch Records (MBR) and electronic Batch Records (eBR), collaborating closely with the manufacturing team to ensure timely finalization of documentation.
- Perform quality inspections of logbooks that are pending review to ensure compliance and completeness.
- Provide quality supervision during the implementation of corrective actions and preventive actions (CAPA) and verify the effectiveness of these actions to sustain production continuity or advance processes to subsequent phases.
- Oversee the resolution of quality documentation, including deviations, change controls, CAPAs, Process Improvements (PI), and Engineering Changes (EC), prioritizing collaboration with interdisciplinary teams to expedite the completion of these records, addressing them in order of receipt or as per the backlog.
- Review and certify scanned copies of GMP documents submitted for archive.
- Additional duties as may be assigned as needed
- GMP
- CAPA
- Process Improvement
- Batch Record Review
- SAP
- Veeva
- CMO Review
- DNA
- lipids
- Experience level: Experienced