Quality Assurance Associate

Biotechnology & PharmaceuticalResearch & Development | Regulatory Affairs About the Company : 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. About the Role : This role involves providing quality assurance oversight and support to manufacturing operations, ensuring compliance with established procedures and regulations. Responsibilities 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 Qualifications B.S. in scientific discipline or equivalent work experience. Required Skills Prior batch record execution or review experience Prior experience in investigation, change control, other Quality Management Systems (QMS) Working knowledge of cGMPs Excellent written and verbal communication and interpersonal skills Must display strong analytical and problem-solving skills Preferred Skills Manufacturing and Manufacturing Sciences experience preferred Seniority level Entry level Employment type Contract Job function Quality Assurance Industries Biotechnology Research Pharmaceutical Manufacturing Research Services #J-18808-Ljbffr Compass Consulting