Scope of Function: 

The Sr. Operations Specialist, QA 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 an independent QA authority on the manufacturing floor, with responsibility for complex investigations, decision-making, 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.

· Lead and support deviation investigations and CAPAs.

· Real-time review and approval of executed batch records, logbooks, and cleaning documentation.

· Support media fills, line clearances, and room/equipment release.

· Review, author, and revise SOPs, batch records, and specifications.

· Support audits, inspections, and inspection readiness.

· Coordinates the archiving of executed manufacturing records with QA Documentation Control.

· Prepares 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. 

Education & Qualifications:

· High school diploma minimum; Associate or Bachelor’s degree preferred.

· Strong knowledge of cGMP, aseptic manufacturing, and data integrity.

· 5–8 years GMP experience; independent floor oversight; leads moderate investigations.