Manufacturing QA Associate (2nd Shift)

Eurofins•Sanford, NC

About The Position

The Manufacturing QA Associate contributes to quality assurance activities on the 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. It supports a compliant site and promotes an empowered culture of quality across functions. The associate reviews batch and other manufacturing documentation in real time, supports transfer of Master Cell Banks to Manufacturing, performs 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 and may approve manufacturing analytical testing performed 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.
Experience in Quality Assurance in GMP facilities; drug substance experience is preferred.
Experience with batch record review, housekeeping monitoring, and 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 floor-level quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance.
Contribute to Quality oversight activities and foster a culture of quality across functions.
Review batch and other manufacturing documentation in real time for errors, corrections, and compliance.
Support transfer of Master Cell Banks to Manufacturing.
Perform facility housekeeping and GMP walkthroughs.
Initiate deviations in real time and assist with investigations.
Work in 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.