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.