Investigation Lead II

Baxter•Round Lake, IL

About The Position

At Baxter, the Investigation Lead II serves as a Quality Investigation & CAPA Lead, directing quality investigations from initial assessment through completion and approval. The role evaluates evidence, tests assumptions and potential causes, and collaborates with cross-functional experts to determine effective responses. Its work supports product quality, regulatory compliance, and operational performance by ensuring investigations are thorough, objective, timely, and inspection-ready. The successful candidate uses analytical thinking, technical judgment, collaboration, and data-driven decision-making to protect patients and customers. The position requires experience in regulated operations and formal investigations, knowledge of quality systems and investigation practices, and the ability to produce clear documentation and defensible conclusions. The estimated base salary is $88,000–$121,000 annually. The position may also be eligible for discretionary bonuses. Applicants must be authorized to work for any U.S. employer; visa sponsorship is not available. Baxter describes comprehensive benefits for eligible U.S. roles, excluding Puerto Rico.

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.
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.
Authorization to work for any employer in the United States; visa sponsorship is not available.

Nice To Haves

Experience supporting FDA, Health Canada, customer, or other regulatory inspections and audit activities.
Knowledge of structured problem-solving methodologies such as 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 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 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 in Quality, Manufacturing, Engineering, Laboratory Operations, and other functions to gather evidence, align on findings, and drive solutions.
Assess potential product, process, compliance, and patient impacts and support risk evaluations and disposition decisions.
Recommend corrective and preventive actions that address identified causes, prevent recurrence, and include measurable effectiveness indicators.
Author clear, concise, inspection-ready investigation reports and maintain complete documentation in the electronic Quality Management System (eQMS).

Benefits

Medical and dental coverage starting on day one for eligible roles.
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 options.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence and paid parental leave.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program (EAP).
Childcare benefits.
Potential eligibility for discretionary bonuses.