Specialist, QA Operations
90 Digital Drive Novato, CA 94949 US
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.
- Associates degree or higher.
- Ability to follow detailed instructions.
- Proficiency with Microsoft office and SharePoint.
- Handle GMP documents and understand the requirements for handling these materials.
- Ability to gown and enter manufacuring clean rooms.
- Operate basic office equipment (printers, scanners).
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.