Investigation Lead II

Milwaukee Succeeds; Round Lake (IL); Sur place; USD 88 000 - 121 000; Plein temps

Avantages offerts par ce poste

Medical and dental coverage starting 1

ESPP (Employee Stock Purchase Plan)

401(k) Retirement Savings Plan

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Analytical thinking

Technical judgment

Collaboration skills

Data-driven decisions

Problem solving

Project management

Communication skills

Formation

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

Outils

TrackWise

Microsoft Office

Description du poste

This is whereyour work makes a difference.

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job-you will find purpose and pride.

This is whereyour work makes a difference.

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job-you will find purpose and pride.

Your Role at Baxter

As a Quality Investigation & CAPA Lead, you will serve as a key driver of quality excellence, leading investigations from initial assessment through completion and approval. You will evaluate evidence, challenge assumptions, test potential causes, and partner with cross-functional experts to determine the most effective path forward.

Your work will directly influence product quality, regulatory compliance, and operational performance by ensuring investigations are thorough, objective, timely, and inspection-ready. Success in this role requires strong analytical thinking, technical judgment, collaboration skills, and a commitment to making data-driven decisions that protect patients and customers.

What You'll Be Doing

• 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).

What You'll Bring

Required Qualifications

• 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.
• 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.

Preferred Qualifications

• 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.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88,000 - $121,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.