QA Operations Associate
Summary
Hands-on, on-the-floor QA professional ensuring GMP compliance during biotech manufacturing operations, providing real-time oversight, batch record review, deviation investigations, and quality risk escalation.
Scope of Function:
The QA Operations Associate is a hands-on, on-the-floor Quality Assurance professional responsible for ensuring GMP compliance during manufacturing operations while exercising independent quality judgment. The role provides real-time QA oversight and acts as a QA representative on the manufacturing floor, with responsibility for assisting in investigations, and escalation of quality risks.
Specific Duties:
· Provide real-time QA presence and oversight for manufacturing operations in classified areas.
· Perform routine and ad hoc GMP walkthroughs to assess compliance and aseptic practices.
· Act as the primary QA point-of-contact during manufacturing activities.
· Exercise independent GMP decision-making, including escalation and stopping operations when required.
· support deviation investigations.
· Real-time review and approval of executed batch records, logbooks, and cleaning documentation.
· Support media fills, line clearances, and room/equipment release.
· Review, SOPs, batch records, and specifications.
· Support audits, inspections, and inspection readiness.
· Coordinates the archiving of executed manufacturing records with QA Documentation Control.
· Supports preparation of batch Certificate of Compliance and Certificate of Assurance, as applicable.
· Provide QA support for the electronic environmental system and the NetSuite enterprise system.
This job description summarizes the primary responsibilities of the role and does not represent a complete list of all duties. Duties and responsibilities may be modified, expanded, or reassigned at any time based on business needs.