Quality Associate III

Baxter International; Round Lake (IL); On-site; USD 96,000 - 132,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Paid holidays and PTO 20–35 days

Commuting benefits

Job summary

Baxter International is seeking a Senior Quality Investigation Lead to steer high-risk, cross-functional investigations within our quality-led program. You will evaluate evidence, determine root causes, and develop preventive actions while coaching teams to strengthen the overall investigation capability.

Strong experience with cGMP, CAPA, and eQMS systems like TrackWise is required. This role focuses on ensuring patient safety and regulatory compliance in a fast-paced environment.

Qualifications

• 5+ years of progressive experience in regulated pharma/biotech/medical device environments.
• 3+ years leading formal investigations, including high-risk events.
• Demonstrated expertise in cGMP regulations, GDPL, CAPA, data integrity, and investigation methodologies.
• Strong writing, analytical, facilitation, and cross-functional collaboration skills.
• Experience communicating with senior leadership, auditors, and inspectors.

Responsibilities

• Lead complex, high-risk investigations from initiation to Quality approval.
• Develop strategies, evidence plans, risk assessments, and decision frameworks for root cause and product impact.
• Direct multidisciplinary teams through evidence collection, analysis, and hypothesis testing.
• Evaluate data from quality, manufacturing, lab, supplier, engineering, and systems to identify root causes and preventive actions.
• Facilitate senior-level discussions to align on findings, risk, and corrective actions.
• Prepare and present investigation reports, exec summaries, and conclusions for audits and inspections.
• Mentor investigators, calibrate cases, and support capability development across the organization.

Skills

Quality investigations leadership

cGMP knowledge

Data analysis

Technical writing

Facilitation and coaching

Education

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

Tools

TrackWise

Job description

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 Senior Quality Investigation Lead, you will serve as a recognized subject matter expert within Baxter's Quality-led investigation program. You will independently lead high-risk, systemic, recurring, and cross-functional investigations while partnering with leaders and technical experts to evaluate evidence, assess product impact, identify root causes, and develop effective corrective and preventive actions.

Beyond individual case ownership, you will help strengthen the overall investigation program through investigator coaching, case calibration, continuous improvement initiatives, and identification of broader quality trends. Your ability to navigate ambiguity, challenge assumptions, and communicate complex technical findings will help ensure quality decisions are objective, defensible, and aligned with patient safety and regulatory expectations.

What You'll Be Doing

• Lead complex, high-risk, systemic, and cross-functional investigations from initiation through independent Quality approval, ensuring timely and comprehensive resolution.
• Develop investigation strategies, evidence plans, risk assessments, and decision frameworks that support accurate root cause determination and product impact evaluation.
• Direct multidisciplinary teams through evidence collection, technical analysis, hypothesis testing, and scientific problem-solving activities.
• Evaluate quality, manufacturing, laboratory, supplier, engineering, and electronic system data to identify root causes, systemic vulnerabilities, and opportunities for preventive action.
• Facilitate senior-level discussions that drive alignment on investigation findings, risk assessments, product impact evaluations, and corrective action strategies.
• Author and present investigation reports, executive summaries, and technical conclusions during internal audits, customer audits, and regulatory inspections.
• Mentor and coach investigators, contribute to calibration activities, and support the development of investigation capabilities across the organization.

What You'll Bring

Required Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or a related technical discipline; an equivalent combination of relevant regulated-industry experience may be considered through an approved equivalency process.
• 5+ years of progressive experience within pharmaceutical, biotechnology, medical device, manufacturing, engineering, laboratory, or Quality operations in a regulated environment.
• 3+ years of experience leading formal investigations, including ownership of complex, recurring, systemic, or high-risk quality events.
• Demonstrated expertise in cGMP regulations, Good Documentation Practices, quality risk management, CAPA systems, data integrity, and investigation methodologies.
• Proven ability to evaluate complex technical evidence, conduct product impact assessments, determine defensible root causes, and develop sustainable corrective and preventive actions.
• Strong technical writing, analytical reasoning, facilitation, project leadership, coaching, and conflict-resolution skills.
• Experience communicating technical and compliance-related information to senior leadership, auditors, inspectors, and cross-functional stakeholders.
• Proficiency with electronic Quality Management Systems (eQMS), such as TrackWise, and data analysis or reporting tools.

Preferred Qualifications

• Advanced degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or related technical discipline.
• Experience defending investigations and presenting conclusions during FDA, Health Canada, customer, or other regulatory inspections.
• Demonstrated experience integrating manufacturing, laboratory, engineering, supplier, complaint, and quality-system data to identify broader systemic risks.
• Lean Six Sigma Green Belt or Black Belt certification.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent quality credential.
• Experience coaching investigators, conducting peer reviews, leading calibration sessions, or supporting investigator qualification programs.

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 $96,000 - $132,000 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. For questions about this, our pay philosophy, and available benefits,

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.

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.

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