Manufacturing QA Associate (2nd Shift)

Eurofins USA PSS Insourcing Solutions•Sanford, NC

3d•Onsite

About The Position

The Manufacturing QA Associate contributes to Quality Assurance floor activities 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. It supports a compliant site and an empowered culture of quality across functions. The position is full-time, Tuesday through Saturday, 3 p.m. to midnight, and is based within commuting distance of Sanford, North Carolina.

Requirements

Bachelor's degree and 2–4 years of relevant experience, or a master's degree and up to 2 years of relevant experience.
Experience in Quality Assurance in GMP facilities; drug substance experience is preferred.
Experience with batch record review, housekeeping monitoring, GMP document review and/or creation, and 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 GMP compliance.
Conduct real-time reviews of batch 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 in accordance with ICH Q7, 21 CFR 211, and internal procedures.
Support or initiate initial investigations of analytical test results on the floor.
Review and potentially approve manufacturing analytical testing on the floor.