Manufacturing Quality Assurance Specialist
6 days ago
Job Summary:
The Manufacturing Quality Assurance Associate contributes to Quality Assurance on the floor activities related to drug substance manufacturing at Eurofins USA PSS Insourcing Solutions. This role is responsible for providing quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance.
Key Responsibilities:
- Performs duties with the guidance of Sr. Associates
- Execute real-time review of batch documentation and other manufacturing documentation analyzing for errors, corrections, and compliance
- Support Transfer Master Cell Banks to Manufacturing
- Perform housekeeping and GMP walkthroughs of facility
- Initiate deviations in real-time and assists in investigations
- Work in cross-functional teams to meet and exceed timelines
- Execute or review room and line clearances
- Makes quality decisions in real-time according to regulations ICH Q7 and 21CFR211 and internal procedures
Additional Responsibilities:
- Support/initiate analytical test results initial investigation on the floor
- Reviews and may approve manufacturing analytical testing on the floor
- Uses analytical skills to help ensure shop floor compliance to internal standards and procedures
- Draft and review Standard Operating Procedures
- Work independently and with minimal supervision
- Provides excellent communication
- Perform other duties as assigned and take ownership to support the implementation of activities needed including but not limited to facility start-up and continuous operations
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