BioMarin Pharmaceutical Inc. · 1 week ago
Sr. Specialist, QA
Novato, CA
Full-time
Hybrid
Mid, Senior Level
2+ years expBioMarin Pharmaceutical Inc. is a global biotechnology company that focuses on translating genetic discoveries into new medicines. The Sr. Specialist, QA is responsible for preparing and performing Quality release for raw materials and product lots manufactured in Novato, ensuring compliance with regulatory standards.
BiotechnologyDeveloper PlatformPharmaceutical
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
Qualification
Required
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
Preferred
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
BA or BS in a technical discipline (physical or biological sciences preferred)
Company
BioMarin Pharmaceutical Inc.
Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery.
1001-5000 employees
H1B Sponsorship
BioMarin Pharmaceutical Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (34)
2024 (23)
2023 (24)
2022 (26)
2021 (24)
2020 (19)
Funding
Current Stage
Public CompanyTotal Funding
$585.8M2020-05-11Post Ipo Debt· $585.8M
1999-07-26IPO
Leadership Team
Brian Mueller
Chief Financial Officer
Arpit Davé
Executive Vice President, Chief Digital and Information Officer
Recent News
2026-01-13
Morningstar.com
2026-01-09
Company data provided by crunchbase