Manages QC staff responsible for the day to day data review function of QC testing of biopharmaceutical product and intermediate, bulk drug substance and drug product, provides leadership and manages performance. This position supports cGMP release and stability testing of product, transfer and validation of analytical methods. Maintains laboratories in a state of GMP readiness.
This Quality Control Data Review Manager is a subject matter expert on review of documentation associated with the operation of a cGMP QC laboratory. Responsibilities include the application of uniform practices for review of analytical raw data and electronic data in the analytical laboratory supporting batch release, stability, cleaning verification, raw materials release, method qualification and method transfer activities. Routine inspection of laboratory documentation for compliance with current industry standards is also within scope.