QA Operations Associate

Description:

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.

Requirements:

Education & Qualifications:

• High school diploma minimum; Associate or Bachelor’s degree preferred.
• Strong knowledge of cGMP, aseptic manufacturing, and data integrity.
• 1 year+ GMP experience; independent floor oversight; support investigations.