QA Operations Associate

4 months initial contract, pay: $40.27/hr

Novato, CA

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Provide quality oversight of one or more portions of operations including, but not limited to: 

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• 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.

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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.