Quality Investigation & CAPA Lead

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

Benefits offered by this job

Medical and dental coverage starting 1

ESPP (Employee Stock Purchase Plan)

401(k) Retirement Savings Plan

Job summary

Baxter is seeking a Quality Investigation & CAPA Lead to drive investigations from intake through resolution, ensuring accuracy and compliance. You will evaluate evidence, test hypotheses, and work with cross-functional teams to determine root causes and effective corrective actions.

Strong analytical and communication skills are required, along with experience in regulated environments and knowledge of eQMS systems such as TrackWise.

Qualifications

• Bachelor’s degree in a regulated industry or equivalent experience.
• 3+ years in pharma/biotech/medical device quality ops or similar.
• 2+ years leading or contributing to investigations, deviations, or CAPA programs.
• Knowledge of cGMP, GDP, investigation processes, CAPA, risk management, data integrity.
• Strong writing, problem-solving, and communication skills.
• Experience with eQMS (TrackWise) and Office tools.

Responsibilities

• Lead investigations from intake to completion with timely, risk-based evaluation of quality events.
• Analyze manufacturing records, lab data, interviews, and reports to identify findings and conclusions.
• Develop hypotheses and determine root causes using structured methods.
• Collaborate with Quality, Manufacturing, Engineering, and Lab ops to gather evidence and drive solutions.
• Assess product, process, and patient impact for risk-based decisions and dispositions.
• Recommend CAPAs with measurable effectiveness and prevent recurrence.
• Produce clear, inspection-ready reports and maintain documentation in eQMS.

Skills

Analytical thinking

Technical judgment

Collaboration skills

Data-driven decisions

Problem solving

Project management

Communication skills

Education

Bachelor's degree in Science/Engineering/Pharmacy/Life Sciences/Quality or related discipline

Tools

TrackWise

Microsoft Office

Job description

Baxter is seeking a Quality Investigation & CAPA Lead to drive investigations from intake through resolution, ensuring accuracy and compliance. You will evaluate evidence, test hypotheses, and work with cross-functional teams to determine root causes and effective corrective actions.

Strong analytical and communication skills are required, along with experience in regulated environments and knowledge of eQMS systems such as TrackWise.