Quality Management Specialist

Global Life Science Hub; Chicago (IL); On-site; USD 75,000 - 110,000; Full time

Job summary

Global Life Science Hub in Chicago is seeking a QMS Specialist with GMP biologics experience to join its growing Quality Systems team. The role focuses on deviations, CAPAs and change controls across upstream and/or downstream operations.

You will review batch records, support inspection readiness, and collaborate with Manufacturing, QA, QC and technical groups to maintain cGMP compliance.

Qualifications

• 2+ years of Quality/QMS experience in GMP pharma/biologics.
• Experience supporting upstream/downstream biologics manufacturing.
• Proficient in deviations, CAPAs, and change controls.
• Experience reviewing GMP batch records and manufacturing documentation.

Responsibilities

• Own deviations, CAPAs, and change controls through investigations.
• Review GMP batch records and manufacturing documentation.
• Support inspection readiness and continued QMS compliance.
• Collaborate with Manufacturing, QA, QC and technical teams.

Skills

Quality/QMS experience

Deviations management

CAPA handling

Investigations

Change controls

GMP knowledge

On-site work

Tools

TrackWise

Veeva

Job description

QMS Specialist - Biologics Manufacturing

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