Quality Management Specialist
Global Life Science Hub
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.
Vacancy posted 8 hours ago
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