Inspection, Review and Disposition of raw material lot files per BioMarin SOPs
Enter raw material lot disposition in LIMS and other databases, as applicable
Maintain electronic status control for cGMP raw materials
Understand the Materials Management and QC raw materials procedures to ensure raw material lot files are compliant with these systems.
Provide QA verification of transfer of FBDS from Manufacturing to Quarantine storage
Perform QA approval of OWK pre-weight kitsPerform QA inspection of primary packaging components
Provide QA support to other QA raw materials activities: BioMarin reserve sample program, in-house label production, control of rejected materials, and in-process materials returned from contract sites.
Attention to detail, organized, ability to work independently with minimal supervision. Primary job function is documentation review, both paper and computer documents. Familiarity with Microsoft Office PC, experience with LIMS or other similar databases a plus.
0-4 years previous experience in a GMP environment.
Bachelor of Science degree in Biology, Biochemistry, Chemistry or related field