Quality Management Specialist

QMS Specialist - Biologics Manufacturing Chicago, IL On-site | Full-time, PermanentGlobal 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 ResponsibilitiesOwn and support deviations, CAPAs and change controls through investigation and closureConduct root cause investigations using tools such as 5-Why and 6MReview GMP batch records and manufacturing documentationSupport Quality events arising from upstream and downstream manufacturingCreate, review and revise SOPsPartner closely with Manufacturing, QA, QC and technical teamsSupport inspection readiness and continued QMS complianceRequirements2+ years of Quality/QMS experience within GMP pharmaceutical or biologics manufacturingExperience directly supporting upstream and/or downstream biologics manufacturingStrong hands-on experience with deviations, CAPAs, change controls and investigationsExperience reviewing GMP manufacturing batch recordsStrong understanding of cGMP requirementsAbility to work full-time on-site in ChicagoHighly Relevant ExperienceMammalian cell culture / bioreactor operationsChromatography / purificationTFF / UF-DF / filtrationCommercial biologics or biosimilar manufacturingTrackWise, Veeva or similar eQMS platformsIf you have a strong QMS background within biologics manufacturing and are open to a new opportunity in Chicago, please apply or reach out directly.