Quality Management Specialist
Global Life Science Hub
QMS Specialist - Biologics Manufacturing Global Life Science Hub is supporting a growing commercial-stage biologics manufacturer looking to expand its Quality Systems team in Chicago. We are looking for a QMS Specialist with experience directly supporting GMP biologics manufacturing , ideally across upstream and/or downstream operations. Key Responsibilities Own and support deviations, CAPAs and change controls through investigation and closure Conduct root cause investigations using tools such as 5-Why and 6M Review GMP batch records and manufacturing documentation Support Quality events arising from upstream and downstream manufacturing Create, review and revise SOPs Partner closely with Manufacturing, QA, QC and technical teams Support inspection readiness and continued QMS compliance Requirements 2+ years of Quality/QMS experience within GMP pharmaceutical or biologics manufacturing Experience directly supporting upstream and/or downstream biologics manufacturing Strong hands-on experience with deviations, CAPAs, change controls and investigations Experience reviewing GMP manufacturing batch records Strong understanding of cGMP requirements Ability to work full-time on-site in Chicago Highly Relevant Experience Mammalian cell culture / bioreactor operations Chromatography / purification TFF / UF-DF / filtration Commercial biologics or biosimilar manufacturing TrackWise, Veeva or similar eQMS platforms #J-18808-Ljbffr Global Life Science Hub
Vacancy posted 2 days ago
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