Specialist

This position reports to the Quality Assurance Supervisor/ Manager/ Senior Manager and is responsible for quality oversight of one or more processes relating to make, assess, and release for 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 Record 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 a plus (additional jurisdictions a plus).

Revise QA related procedures as needed.

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