Job Details :

Specialist, QA Operations in Novato, CA

12 Months Contract

General Shift (Mon - Fri)

Job Responsibilities :

This position reports to the Quality Assurance Supervisor / Manager / Senior Manager and is responsible for quality oversight of one or more processes relating to making, assessing, and releasing products produced in Novato manufacturing facilities.

The responsibilities in the role include the following :

• Provide quality oversight of one or more portions of operations including, but not limited to;
• Direct observation of manufacturing operation for adherence to GMP.
• Review of GMP documentation from manufacturing and / or QC, which can include log books, batch records, and test records.
• Issuance of Production Batch Records to Manufacturing
• Scanning and archiving executed production batch records
• Ensure manufacturing and QC adherence to company policies / procedures, regulatory licenses, industry standards, and GMP regulations.

Working knowledge of United States and European regulatory requirements, guidelines, and recommendations is a plus (additional jurisdictions a plus).

Revise QA-related procedures as needed.

Skills :

• Attention to detail.
• MS Office.
• Ability to operate basic office equipment, e.g. scanners, and printers.

Required

• SCANNING
• DOCUMENTATION
• BATCH RECORD
• ARCHIVING

Additional

• PRINTERS
• BATCH RECORDS
• OPERATIONS
• MICROSOFT OFFICE
• QUALITY ASSURANCE
• MS OFFICE

Education :

• Associate degree or higher.
1 hour ago