QA Operations Associate
Novato, CA
03+ Months
Provide quality oversight of one or more portions of operations including, but not limited to:
- 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.
- Production and batch records experience highly desired
Skills:
Attention to detail. GDP understanding required. Microsoft Office. Oracle EBS. Ability to operate basic office equipment (e.g., scanners, printers). SQL, as a plus.
Education:
Associate degree or higher.
Regards,
Lakshmi
