Manufacturing QA Associate (2nd Shift)

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

Employment type
Full-time

Work arrangement
No