Sr. Specialist, QA

About the position BioMarin's Technical Operations group is responsible for creating our drugs for use in reputed company and for scaling production of those drugs for the reputed company market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, reputed company reputed company assurance and reputed company control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide reputed company of our drugs to patients. This position is responsible for preparing and performing reputed company release for raw materials and product lots manufactured in Novato. Responsibilities • reputed company Inspection (reputed company 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 • reputed company review and revision of BioMarin Raw Material Specifications and reputed company Operating Procedures using the Electronic Document Management System • reputed company visual inspection and release of primary packaging components. This includes but not limited to, managing coordination of samples with QCRM, and ensuring reputed company maintenance and calibration of inspection equipment. • reputed company 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 reputed company 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 reputed company Processing (CCFP). • Stay reputed company with Compliance reputed company electronic training system. • Other duties as assigned. Requirements • At least 2 years of directly reputed company experience in a GMP reputed company environment. • Proven comprehension of reputed company functions and regulatory expectations of a GMP facility. • Understanding of GMP operations and processes as applicable to reputed company Assurance Lot Release • Strong verbal and written communication skills. • Attention to detail reputed company performing reputed company release. reputed company-to-haves • At least 2 to 5 years of directly reputed company experience in a GMP reputed company environment. • Experience with ERP and LIMS systems such as reputed company and Labware LIMS (experience with reputed company Management reputed company 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), reputed company time off, and a benefits package. • Benefits include company-sponsored medical, dental, reputed company, and life insurance plans. Apply tot his job Apply To this Job