This position is responsible for performing BioMarin Quality Assurance (QA) review of BioMarin 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.
Bachelor of Science degree in Biology, Biochemistry, Chemistry or related field