goodwin biotechnologyFort Lauderdale, FL
QA Operations Associate
QA Operations Associate
QA Operations Associate
goodwin biotechnologyFort Lauderdale, FL
5 days ago
Quality Control Systems ManagersQuality Control AnalystsInspectors, Testers, Sorters, Samplers, and Weighers
Pharmaceutical Preparation ManufacturingBiological Product ManufacturingMedicinal and Botanical Manufacturing
Apply for this role (opens in a new tab)Job Description: Job Description
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.
Also on the board Same function, level within a rung
Level
Junior
Location
Fort Lauderdale, FL
Occupation
Quality Control Systems Managers
Industry
Pharmaceutical Preparation Manufacturing
Posted
5 days ago