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.
Other QALR duties as assigned.
Bachelor s degree in science or Degree in Chemical Engineering
0 2 years relevan experience
Working knowledge of desktop computers (ie: Excel, Microsoft Word).
Bachelor of Science degree in Biology, Biochemistry, Chemistry or related field.