Sr. QA Specialist, Operations

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.

• 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.
• Coordinate the archiving of executed manufacturing records with QA Documentation Control.
• Prepare batch Certificate of Compliance and Certificate of Assurance, as applicable.
• Provide QA support for the electronic environmental system and the Net Suite 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.

• 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.