Quality Assurance Specialist
Marin Metro Area, CA
- Perform QA review of production records and other documentation associated with production and release of Biological products per QA SOPs
- Receive, control, scan and archive of completed manufacturing production records
- Update QA databases for batch record review status
- Prepare and compile batch record lot history files for Cell Culture or Formulated bulk drug substance (FBDS) lots.
- Interact with Manufacturing personnel
- Expected to exercise some independent judgment within the job responsibilities and perform the job responsibilities with minimum supervision.
- Understand QA systems such as raw material disposition, deviations, and change control to ensure batch records are compliant with these systems.
- 0-2 years relevant experience
- Working knowledge of desktop computers (ie: Excel, Microsoft Word).
- Bachelor of Science degree in Biology, Biochemistry, Chemistry, Chemical Engineering or related field.