Investigation Lead II

Baxter International; Round Lake (IL); Presencial; USD 88.000 - 121.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance and dental coverage

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Paid time off 20–35 days

Descripción de la vacante

Baxter International is seeking a Quality Investigation & CAPA Lead in Round Lake, IL. You will drive investigations from intake through closure, evaluate evidence, test hypotheses, and partner with Quality, Manufacturing, and Engineering to implement effective CAPAs that improve product quality and regulatory readiness.

Minimum requirements include a science/engineering degree and 3+ years in a regulated quality environment, plus proficiency with TrackWise and MS Office.

Formación

• Bachelor's degree in a relevant technical field or equivalent regulated-industry experience.
• 3+ years in pharmaceutical/biotech/medical device quality operations in a regulated setting.
• 2+ years leading investigations, deviations, nonconformances, or CAPA programs.
• Working knowledge of cGMP, GDP, investigation processes, CAPA, and data integrity.
• Strong writing, problem solving, and communication skills.
• Experience with eQMS systems (TrackWise) and Microsoft Office.

Responsabilidades

• Lead quality investigations from intake to completion with risk-based evaluation.
• Analyze manufacturing records, lab data, interviews, and reports to support conclusions.
• Develop hypotheses to identify root causes using structured methods.
• Collaborate with Quality, Manufacturing, Engineering, and other functions.
• Assess impacts and support risk evaluations and disposition decisions.
• Recommend CAPAs with measurable effectiveness indicators.
• Write clear inspection-ready investigation reports and maintain eQMS records.

Conocimientos

cGMP knowledge

Root cause analysis

Data-driven decisions

Technical writing

Cross-functional collaboration

Investigation execution

eQMS (TrackWise)

Microsoft Office

Educación

Bachelor's degree in Science/Engineering/Pharmacy/Life Sciences

Herramientas

TrackWise

Descripción del empleo

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).

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. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter.

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.

25212 W Illinois Route 120 RL/Drug|Round Lake, IL 60073|United States of America