Job Summary:

Perform data review for commercial program documents including Process Performance Verification (PPQ) reports, Continuous Process Verification (CPV report) and any other reports supporting process validation for monoclonal antibodies, recombinant proteins, peptides and other biologics. This review includes the verification that calculations and documented information are correct, complete, and accurate in accordance with guidance documents and internal procedures. Make detailed observations and report documentation corrections to the relevant personnel, as needed.

Job Responsibilities (Approximate % of Time):