Job Details

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. Duties: Provide on-the-floor QA oversight and support to manufacturing operations Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations Represent QA in support of deviations including active participation in Root Cause Analysis (RCA) Provide cGMP and compliance guidance to Manufacturing and Novato Technical Services (NTS) personnel Provide QA support including authoring, review, and approval of documents in Quality Management Systems in accordance with BioMarin policies Perform area walkthroughs Perform other duties and projects as assigned by management...QA, Associate, Technology, Staffing