QA Operations Associate
90 Digital Drive Novato, CA 94949 US
Job Description
- Review of GMP documentation from manufacturing, which can include but is not limited to logbooks, production batch records and electronic buffer & media batch records.
- Scanning and archiving executed production batch records.
- Ensure manufacturing 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).
- Perform other duties and projects as assigned by management.
Requirements:
- Associate degree or higher.
- Production and batch records experience highly desired
- Attention to detail.
- GDP understanding required.
- Microsoft Office.
- Oracle EBS.
- Ability to operate basic office equipment (e.g., scanners, printers). SQL, as a plus.
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