Biologics QMS Specialist - Onsite Chicago

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

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.