Senior Quality Investigation & CAPA Lead

Baxter International; Round Lake (IL); On-site; USD 88,000 - 121,000; Full time

Benefits offered by this job

Health insurance and dental coverage

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Paid time off 20–35 days

Job summary

Baxter International is seeking a Quality Investigation & CAPA Lead in Round Lake, IL. You will drive investigations from intake through closure, evaluate evidence, test hypotheses, and partner with Quality, Manufacturing, and Engineering to implement effective CAPAs that improve product quality and regulatory readiness.

Minimum requirements include a science/engineering degree and 3+ years in a regulated quality environment, plus proficiency with TrackWise and MS Office.

Qualifications

• Bachelor's degree in a relevant technical field or equivalent regulated-industry experience.
• 3+ years in pharmaceutical/biotech/medical device quality operations in a regulated setting.
• 2+ years leading investigations, deviations, nonconformances, or CAPA programs.
• Working knowledge of cGMP, GDP, investigation processes, CAPA, and data integrity.
• Strong writing, problem solving, and communication skills.
• Experience with eQMS systems (TrackWise) and Microsoft Office.

Responsibilities

• Lead quality investigations from intake to completion with risk-based evaluation.
• Analyze manufacturing records, lab data, interviews, and reports to support conclusions.
• Develop hypotheses to identify root causes using structured methods.
• Collaborate with Quality, Manufacturing, Engineering, and other functions.
• Assess impacts and support risk evaluations and disposition decisions.
• Recommend CAPAs with measurable effectiveness indicators.
• Write clear inspection-ready investigation reports and maintain eQMS records.

Skills

cGMP knowledge

Root cause analysis

Data-driven decisions

Technical writing

Cross-functional collaboration

Investigation execution

eQMS (TrackWise)

Microsoft Office

Education

Bachelor's degree in Science/Engineering/Pharmacy/Life Sciences

Tools

TrackWise

Job description

Baxter International is seeking a Quality Investigation & CAPA Lead in Round Lake, IL. You will drive investigations from intake through closure, evaluate evidence, test hypotheses, and partner with Quality, Manufacturing, and Engineering to implement effective CAPAs that improve product quality and regulatory readiness.

Minimum requirements include a science/engineering degree and 3+ years in a regulated quality environment, plus proficiency with TrackWise and MS Office.