Manufacturing QA Associate (2nd Shift)

Eurofins USA PSS Insourcing Solutions•Sanford, NC

About The Position

The Manufacturing QA Associate supports Quality Assurance activities on the manufacturing floor related to drug substance manufacturing. The role uses fundamental GMP knowledge and established procedures to provide quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance, and helps maintain a compliant site while fostering a culture of quality across functions. The Associate performs real-time reviews of batch and other manufacturing documentation, supports Master Cell Bank transfers to Manufacturing, conducts facility housekeeping and GMP walkthroughs, initiates deviations and assists with investigations, and works with cross-functional teams to meet timelines. The role also executes or reviews room and line clearances, makes real-time quality decisions under ICH Q7, 21 CFR 211, and internal procedures, supports or initiates initial investigations of analytical test results on the floor, and reviews or may approve manufacturing analytical testing on the floor.

Requirements

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 experience in GMP facilities; drug substance experience preferred.
Experience with batch record review, housekeeping monitoring, GMP document review and/or creation.
Experience reviewing deviation reports, change controls, CAPA, and analytical data.
Experience with data integrity.
Knowledge of and experience with GMP and applicable regulations, or willingness to become GMP proficient.

Nice To Haves

Quality Assurance experience in drug substance manufacturing.

Responsibilities

Provide quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance.
Contribute to site quality oversight activities and foster a culture of quality across functions.
Perform real-time reviews of batch records and other manufacturing documentation for errors, corrections, and compliance.
Support the transfer of Master Cell Banks to Manufacturing.
Conduct facility housekeeping and GMP walkthroughs.
Initiate deviations in real time and assist with investigations.
Work with cross-functional teams to meet and exceed timelines.
Execute or review room and line clearances.
Make real-time quality decisions according to ICH Q7, 21 CFR 211, and internal procedures.
Support or initiate initial investigations of analytical test results on the floor.
Review and may approve manufacturing analytical testing on the floor.