Quality Investigation & CAPA Lead

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

Benefits offered by this job

Health and dental benefits

Employee stock purchase plan (ESPP)

401(k) Retirement Plan

Paid time off 20–35 days

Job summary

Baxter is seeking a Quality Investigation & CAPA Lead to drive investigations from intake to completion, ensuring timely, risk-based evaluations of quality events and nonconformances. You will analyze manufacturing records, lab data, and interviews to form defensible conclusions and propose CAPAs with measurable effectiveness.

You will partner with Quality, Manufacturing, Engineering, and Laboratory Operations to ensure documentation is inspection-ready and compliant with cGMP and data integrity

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or a related technical discipline or equivalent regulated-industry experience.
• 3+ years of experience within pharmaceutical, biotechnology, medical device, manufacturing, laboratory, engineering, or quality operations in a regulated environment.
• 2+ years of experience leading or significantly contributing to formal investigations, deviations, nonconformances, customer complaints, or CAPA programs.
• Working knowledge of cGMP requirements, Good Documentation Practices, investigation processes, CAPA principles, quality risk management, and data integrity expectations.
• Demonstrated ability to evaluate evidence objectively, perform root cause analysis, and develop defensible, data-based conclusions.
• Strong technical writing, problem-solving, project management, facilitation, and communication skills.
• Experience working with electronic Quality Management Systems (eQMS), such as TrackWise, and Microsoft Office applications.

Responsibilities

• Lead quality investigations from intake through completion, ensuring timely, risk-based evaluation of quality events, deviations, complaints, or nonconformances.
• Analyze evidence from manufacturing records, laboratory data, interviews, process observations, and technical reports to identify findings and support objective conclusions.
• Develop and test multiple hypotheses to determine direct, contributing, and root causes using structured investigation methods.
• Partner with subject matter experts across Quality, Manufacturing, Engineering, Laboratory Operations, and other functions to gather evidence and drive solutions.
• Assess potential product, process, compliance, and patient impacts while supporting risk evaluations and disposition decisions.
• Recommend corrective and preventive actions (CAPAs) addressing identified causes and including measurable indicators of effectiveness.
• Author clear, inspection-ready investigation reports and maintain documentation within the eQMS.

Skills

Analytical thinking

Data-driven decision making

Strong writing & communication

Project management

Education

Bachelor's degree in Science or related technical discipline

Tools

TrackWise

Microsoft Office

Job description

Baxter is seeking a Quality Investigation & CAPA Lead to drive investigations from intake to completion, ensuring timely, risk-based evaluations of quality events and nonconformances. You will analyze manufacturing records, lab data, and interviews to form defensible conclusions and propose CAPAs with measurable effectiveness.

You will partner with Quality, Manufacturing, Engineering, and Laboratory Operations to ensure documentation is inspection-ready and compliant with cGMP and data integrity