Sr. Specialist, QA

Sr. Specialist, QA at Bio Space

Novato, CA

Bio Marin’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 Bio Marin’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.

• 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 Bio Marin 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.

Required Skills: 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.

Desired

Skills:

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).

This position does not utilize any specific equipment.

This position will require interaction primarily with the Manager of QA Lot Release and other QA Associates and Sr. Specialists within the QA Lot Release team. This position may also interact with other departments and levels within Quality Assurance and Quality Control such as but not limited to the Quality Site Head, Director of Quality Assurance, Associates and Specialists within Quality Assurance Frontline, Associates and Technical Managers within Quality Assurance Operations, as well as Quality Control analysts and management.

This position is expected to work from Monday to Friday at the standard day shift hours (9 am to 5 pm). This position may require work during off hours, holidays, and/or weekends, as needed to maintain critical business operations.

This position is expected to be primarily onsite, however some remote work up to 2 days a week can be performed with approval of the QA Lot Release Manager.

Travel is not a requirement for this position.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Bio Marin is a global biotechnology company that relentlessly pursues…