Investigation Lead II

Baxter International Inc. • Round Lake, IL

1d • $88,000 - $121,000

About The Position

The Quality Investigation & CAPA Lead drives quality excellence by leading investigations from initial assessment through completion and approval. The role evaluates evidence, challenges assumptions, tests potential causes, and works with cross-functional experts to determine effective paths forward. Its work influences product quality, regulatory compliance, and operational performance by ensuring investigations are thorough, objective, timely, and inspection-ready. Success requires analytical thinking, technical judgment, collaboration, and data-driven decision-making that protects patients and customers.

Requirements

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or a related technical discipline, or an equivalent combination of education and directly relevant regulated-industry experience.
• At least 3 years of experience in pharmaceutical, biotechnology, medical device, manufacturing, laboratory, engineering, or quality operations in a regulated environment.
• At least 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.
• 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 with electronic Quality Management Systems (eQMS), such as TrackWise, and Microsoft Office applications.

Nice To Haves

• Experience supporting FDA, Health Canada, customer, or other regulatory inspections and audit activities.
• Knowledge of structured problem-solving methodologies, including 5 Whys, Fishbone/Ishikawa Analysis, DMAIC, Fault Tree Analysis, or similar approaches.
• Experience using reporting, visualization, or statistical analysis tools to identify trends and support decision-making.
• Lean Six Sigma Green Belt, ASQ certification, or equivalent quality and process improvement credentials.
• Experience working in pharmaceutical, biotechnology, or medical device manufacturing environments with complex quality systems.

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 and problem-solving methodologies.
• Partner with subject matter experts across Quality, Manufacturing, Engineering, Laboratory Operations, and other functions to gather evidence, align on findings, and drive effective solutions.
• Assess potential product, process, compliance, and patient impacts while supporting appropriate risk evaluations and disposition decisions.
• Recommend corrective and preventive actions (CAPAs) that address identified causes, prevent recurrence, and include measurable indicators of effectiveness.
• Author clear, concise, inspection-ready investigation reports and maintain complete documentation within the electronic Quality Management System (eQMS).

Benefits

• Medical and dental coverage starting on day one
• Basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan with employee contributions and company matching
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays
• Paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits
• May be eligible for discretionary bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level