Quality Investigation Lead — CAPA & Compliance Excellence

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

Benefits offered by this job

Health benefits

401(k) plan

Paid time off

Tuition assistance

Job summary

Baxter International Inc. is seeking a Quality Investigation & CAPA Lead in Illinois. You will drive investigations from intake to resolution, analyze evidence from multiple sources, and collaborate with cross-functional teams to determine root causes and effective CAPAs.

The role emphasizes data-driven decision making and thorough, inspection-ready documentation. The position requires strong technical writing, GMP knowledge, and experience with eQMS like TrackWise.

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or related discipline.
• 3+ years in pharma/biotech/medical device or regulated environments.
• 2+ years leading investigations, deviations, or CAPA programs.
• Working knowledge of cGMP, GDP, investigations, CAPA, quality risk management, and data integrity.
• Ability to evaluate evidence, perform root cause analysis, and draw data-based conclusions.
• Strong writing, problem-solving, project management, facilitation, and communication skills.
• Experience with eQMS such as TrackWise and MS Office applications.

Responsibilities

• Lead investigations from intake to completion with timely, risk-based evaluation.
• Analyze manufacturing records, labs, interviews to identify findings.
• Develop and test hypotheses to identify root causes.
• Collaborate with Quality, Manufacturing, Engineering to drive solutions.
• Assess product, process, compliance, and patient impacts; support risk evaluations.
• Recommend CAPAs with measurable effectiveness indicators.
• Prepare inspection-ready reports in the eQMS.

Skills

Quality investigations

Root cause analysis

Data-driven decisions

Technical writing

Project management

Cross-functional collaboration

Communication skills

eQMS TrackWise

Microsoft Office

Education

Bachelor's degree in Science/Engineering

Tools

TrackWise

Microsoft Office

Job description

Baxter International Inc. is seeking a Quality Investigation & CAPA Lead in Illinois. You will drive investigations from intake to resolution, analyze evidence from multiple sources, and collaborate with cross-functional teams to determine root causes and effective CAPAs.

The role emphasizes data-driven decision making and thorough, inspection-ready documentation. The position requires strong technical writing, GMP knowledge, and experience with eQMS like TrackWise.