Quality Assurance Specialist
Randstad USA · Norwood, MA · 1 mo ago
On-siteQuality Assurance$45–$54.86/hrContract
Job Summary
Responsibilities
- Provide real-time QA oversight on the manufacturing floor, conducting regular walkthroughs and real-time process observations.
- Review and approve electronic and paper batch production records to ensure strict cGMP compliance.
- Support deviation management, root-cause investigations, and corrective action execution.
- Perform alarm acknowledgments, equipment monitoring, and cleanroom behavior oversight.
- Partner with cross-functional teams on raw material release, plasmid/drug substance disposition, and SOP reviews.
- Maintain strict adherence to data integrity standards and site quality guidelines.
Qualifications
- Required: Bachelor's Degree or equivalent years of experience in GMP experience in QA, training or document control experience in the biotechnology/biopharmaceutical industry, or other regulated industry.
- Knowledge of FDA, EU, ICH guidelines, and relevant regulations.
- Experience with quality systems, including batch record review, deviation management, and change control.
Preferred
- Proficiency in authoring and reviewing GMP documentation.
- Familiarity with environmental monitoring and microbiological testing.