Sr. Specialist, QA
About the position BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. This position is responsible for preparing and performing Quality release for raw materials and product lots manufactured in Novato. Responsibilities • Perform Inspection (when applicable), Review, and Disposition of incoming raw materials at the Novato GMP Warehouse(s) • Maintain electronic status control and data entry in ERP system for GMP raw materials • Quality review and revision of BioMarin Raw Material Specifications and Standard Operating Procedures using the Electronic Document Management System • Perform visual inspection and release of primary packaging components. This includes but not limited to, managing coordination of samples with QCRM, and ensuring timely maintenance and calibration of inspection equipment. • Provide QA support to other QA raw materials activities: Control of rejected materials, material return program, and other Warehouse QA responsibilities, as assigned • Verify deviation closure in electronic QMS and QC sample results in LIMS. • Prepare and assemble the production batch record lot files and supplemental files for FBDS/DP lot release. • Responsible for the preparation of FBDS/DP documentation, including preparation of the Approval Checklist and Certificate of Compliance For Further Processing (CCFP). • Stay current with Compliance Wire electronic training system. • Other duties as assigned. Requirements • At least 2 years of directly related experience in a GMP Quality environment. • Proven comprehension of Quality functions and regulatory expectations of a GMP facility. • Understanding of GMP operations and processes as applicable to Quality Assurance Lot Release • Strong verbal and written communication skills. • Attention to detail when performing Quality release. Nice-to-haves • At least 2 to 5 years of directly related experience in a GMP Quality environment. • Experience with ERP and LIMS systems such as SAP and Labware LIMS (experience with Quality Management within ERP is a plus). • Experience and familiarity with Manufacturing Execution System (MES) are a plus. Benefits • This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. • Benefits include company-sponsored medical, dental, vision, and life insurance plans. Apply tot his job