Manufacturing Medical Quality Analyst
Massachusetts Health & Hospital Association · Pompano Beach, FL · 2 mo ago
Quality AssuranceFull-time
About the role
Responsible for reviewing and approving batch records during manufacturing to ensure compliance with quality standards.
Responsibilities
- Complete batch record reviews
- Identify issues and open non-conformances
- Support quality record retention
- Coordinate with manufacturing for DHR corrections
- Collaborate with QC and Microbiology teams
- Interact with regulators as needed
Requirements
- 2+ years of experience in a medical or manufacturing environment or a high school diploma with 3-5 years of relevant experience
- Knowledge of 21CFR Part 820, cGMPs, ISO 9001, and Quality Information Systems (Trackwise, OTIS, Windchill, SAP)
- Proficiency in Microsoft Office
- Ability to work independently or in teams
Skills
- Flexibility and adaptability
- Strong communication and conflict resolution
- Organizational skills
- Commitment to safety and ethical standards