Quality Assurance Specialist, Lot Release
San Francisco Metro Area, CA
- This position is responsible for performing Quality Assurance (QA) review of commercial manufacturing batch records and associated documentation. This includes receipt, QA review and archival of executed manufacturing batch records and associated documentation such as QC test forms, and updating QA databases. QA review of commercial manufacturing batch records includes verifying conformance to cGMPs and BioMarin SOPs and batch record process limits.
- This position is a junior level individual contributor position. The individual is expected to be capable of performing routine job functions with minimal supervision. The Specialist I/II is expected to communicate well with Manufacturing, Quality Assurance, and Quality Control.
- Perform QA review of Commercial Manufacturing executed batch records and associated documentation for compliance with cGMPs, SOPs, and other policies and procedures.
- Receive, control, scan and archive Commercial Manufacturing executed batch records.
- Review electronic data in Oracle EBS and compare with Paper batch records for consumption.
- Prepare lot history folders for Novato formulated bulk drug substance (FBDS) lots.
- Other QA Lot Release duties as assigned.
- For Specialist I, 0-2 years of directly related experience in a GMP Quality or Manufacturing environment.
- Bachelor of Science degree in Biology, Biochemistry, Chemistry or related field