Quality Management Specialist

QMS Specialist - Biologics Manufacturing

? Chicago, IL

? 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 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

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.