The Manufacturing QA Associate contributes to Quality Assurance on the floor activities related to drug substance manufacturing.
- Use fundamental knowledge of GMP, and established procedures methodologies to provide quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance
- Ensure the site performs in a state of compliance by contributing to Quality oversight activities while fostering an empowered culture of quality across all functions
- 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 assist in investigations
- Work in cross-functional teams to meet and exceed timelines
- Execute or review room and line clearances
- Make quality decisions in real-time according to regulations ICH Q7 and 21CFR211 and internal procedures
- Support/initiate analytical test results initial investigation on the floor
- Reviews and may approve manufacturing analytical testing on the floor
- Bachelor's degree and 2-4 years of relevant experience or a Master's degree and up to 2 years of relevant experience
- Quality Assurance in GMP facilities, drug substance preferred
- Batch record review, housekeeping monitoring, GMP document review and/or creation.
- Reviewing deviation reports, change controls, CAPA, and analytical data.
- Experience with Data Integrity
- Knowledge of and experience in GMP, following applicable regulations, or willingness to become GMP proficient
This position is Full-Time, Tuesday-Saturday 3pm-12am. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply.
- Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.