Manufacturing QA Associate (2nd Shift)

Eurofins USA PSS Insourcing Solutions•Sanford, NC

1d•Onsite

About The Position

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.

Requirements

Bachelor's Degree in Microbiology or related field (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.)
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

Responsibilities

Provide quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance.
Contribute 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.