Manages and coordinates activities and resources associated with Quality Assurance overseeing Lab activities and controls to include the approval of incoming and finished product testing data, lab OOS and non-conformance, stability, raw material, component, calibration, and lab equipment qualification.
Bachelor’s Degree with a major in Chemistry, Engineering or Biological/Chemical Science.
10 years in pharmaceutical or medical device FDA GxP environment and 5+ years of supervisory experience. Thorough knowledge and understanding of data integrity
Thorough knowledge of pharmaceutical manufacturing/controls and Good Laboratory Practices.