Quality Management Specialist
global life science hubChicago, IL
Quality Management Specialist
global life science hubChicago, ILSenior L5
Quality Control Systems ManagersQuality Control AnalystsInspectors, Testers, Sorters, Samplers, and Weighers
Pharmaceutical Preparation ManufacturingBiological Product (except Diagnostic) ManufacturingResearch and Development in Biotechnology (except Nanobiotechnology)
APPLY NOWQMS Specialist - Biologics Manufacturing馃搷 Chicago, IL馃彚 On-site | Full-time, Permanent 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 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
- TrackWise, 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.
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Level
Senior L5
Location
Chicago, IL
Occupation
Quality Control Systems Managers
Industry
Pharmaceutical Preparation Manufacturing
Posted
10 days ago