QA Operations Analyst I — cGMP & Deviation Investigator

CSL; Kankakee (IL); On-site; USD 32,000 - 42,000; Full time

Job summary

CSL is seeking an entry-level Quality Assurance Operations associate in Illinois. The role develops responsibilities including assisting with deviation investigations, participating in root-cause analyses, and ensuring cGMP compliance on the production floor with real-time batch record review.

You will support training related to investigations and continuous improvement, collaborate with manufacturing personnel, and assist with annual inspections and sample retention activities as part of the

Qualifications

• 0–2 years in a cGMP environment preferred.
• Technical writing experience is preferred.
• TrackWise knowledge a plus.

Responsibilities

• Assist with investigating deviations and participate in investigation meetings.
• Review batch records in real time and support cGMP compliance.
• Support root cause analysis and CAPA activities.
• Collaborate with manufacturing personnel during deviations.
• Assist with maintaining sample retention areas and annual inspections.

Skills

Verbal communication

Written communication

Conflict management

Learning on the fly

Dealing with ambiguity

Action oriented

Education

B.A./B.S. in science/tech

Tools

TrackWise

Job description

CSL is seeking an entry-level Quality Assurance Operations associate in Illinois. The role develops responsibilities including assisting with deviation investigations, participating in root-cause analyses, and ensuring cGMP compliance on the production floor with real-time batch record review.

You will support training related to investigations and continuous improvement, collaborate with manufacturing personnel, and assist with annual inspections and sample retention activities as part of the