Sr. Specialist, QA

Role Summary

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.

Qualifications

• Required: At least 2 years of directly related experience in a GMP Quality environment.
• Required: Proven comprehension of Quality functions and regulatory expectations of a GMP facility.
• Required: Understanding of GMP operations and processes as applicable to Quality Assurance Lot Release
• Required: Strong verbal and written communication skills.
• Required: Attention to detail when performing Quality release.
• Preferred: At least 2 to 5 years of directly related experience in a GMP Quality environment.
• Preferred: Experience with ERP and LIMS systems such as SAP and Labware LIMS (experience with Quality Management within ERP is a plus).
• Preferred: Experience and familiarity with Manufacturing Execution System (MES) are a plus.

Education

• BA or BS in a technical discipline (physical or biological sciences preferred).

Additional Requirements

• 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.
• Shift: Monday to Friday, 9 am to 5 pm; may require work during off hours, holidays, and/or weekends as needed to maintain operations.
• Travel: Travel is not a requirement for this position.