Quality Management Specialist

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 6MReview GMP batch records and manufacturing documentation Support Quality events arising from upstream and downstream manufacturing Create, review and revise SOPsPartner 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 / purificationTFF / UF-DF / filtration Commercial biologics or biosimilar manufacturing Track Wise, Veeva or similar eQMS platforms If you have a strong QMS background within biologics manufacturing and are open to a new opportunity in Chicago, please apply or reach out directly.