Sr. Operations Specialist, QA
Goodwin Biotechnology Inc•Plantation, FL
•Onsite
About The Position
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.
Requirements
- 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.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
