Description:
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.
Requirements:
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.
