QC Scientist Group Leader

General Description:Supervise the Quality Control functions executed by a small team and provide direct support of Quality Control processes, test procedures, and procedure validation activities. Measure, generate and evaluate data for the Certificates of Analysis to support testing of in-process samples, manufactured Bulk Drug Substance and Drug Product lots.Job Responsibilities:Manage a staff of Quality Control analysts ensuring that day-to-day scheduling of activities is appropriately resourced.Maintain raw material release testing program.Manage laboratory equipment upkeep, calibration, and preventive maintenance and ensure proper documentation in logbooks and electronic management systems.Ensure all method qualification or validation is current. Test procedures include bioassay methods, binding assays, flow cytometry, gene expression analysis, and microbial control assays.Keep apprised of compendial changes and ensure compliance with compendia for all test procedures.Manage external vendors providing lab services and materials.Maintain laboratory housekeeping including organization, cleanliness, and logbooks.Maintain appropriate inventory of materials through effective order management, coordination with Finance, and adherence to departmental budget.Ensure timely Quality Control testing is performed on incoming raw materials, intermediate Bulk Drug Substance, and final drug product.Participate in the establishment of phase-appropriate specifications.Ensure data integrity is maintained for all applications, programs, and executed work. Ability to document all work using Good Documentation Practices and ALCOA principles.Generate protocols and technical reports.Author and manage QC change controls, test procedure revisions, SOP and ATM revisions, laboratory investigations, and root cause analyses.Raise critical quality issues to upper management.Perform internal audits to ensure compliance with cGMP’s.Write and revise Quality Systems SOPs as necessary to maintain compliance.Train and develop employees.Ensure full compliance with applicable health and safety regulations (such as OSHA).