Quality Management Specialist

global life science hubOak Park, IL4 days ago

Occupations

Quality Control Systems Managers Quality Control Analysts Inspectors, Testers, Sorters, Samplers, and Weighers

Industries

Biological Product (except Diagnostic) Manufacturing Pharmaceutical Preparation Manufacturing Research and Development in Biotechnology (except Nanobiotechnology)

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 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.

Apply now

Level

SeniorL5

Location

Oak Park, IL

Occupation

Quality Control Systems Managers

Industry

Biological Product (except Diagnostic) Manufacturing

Posted

4 days ago

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