Quality Associate III

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

Benefits offered by this job

Health & dental coverage

401(k) with company match

Paid time off

Job summary

Baxter is seeking a Senior Quality Investigation Lead in the United States. You will independently lead high-risk, systemic investigations, partnering with leaders and technical experts to evaluate evidence, assess product impact, and develop corrective actions.

You will coach investigators and strengthen the program through calibration and continuous improvement efforts. You will communicate findings to senior leadership and participate in internal and regulatory inspections, ensuring adherence

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, or related field.
• 5+ years in regulated pharmaceutical/biotech/medical device operations.
• 3+ years leading formal investigations of quality events.
• Experience with cGMP, GxP, CAPA, data integrity, and investigation methodologies.
• Strong writing, analytical reasoning, facilitation, and leadership skills.
• Experience communicating to senior leadership, auditors, inspectors, and cross-functional stakeholders.
• Proficiency with eQMS (TrackWise) and data analysis/reporting tools.

Responsibilities

• Lead high-risk, systemic investigations from initiation to Quality approval.
• Develop investigation strategies, evidence plans, risk assessments, and decision frameworks.
• Direct multidisciplinary teams through evidence collection, hypothesis testing, and analysis.
• Evaluate data from quality, manufacturing, lab, supplier, engineering, and electronics systems to identify root causes.
• Facilitate senior-level discussions on findings, risk, and corrective actions.
• Prepare investigation reports, executive summaries, and technical conclusions for audits and inspections.
• Mentor investigators and support calibration activities across the organization.

Skills

Subject matter expert in quality

cGMP regulations

Data analysis

Project leadership

Senior stakeholder communication

Mentoring investigators

Education

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

Advanced degree preferred

Tools

TrackWise

Data analysis tools

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.

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

• 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.

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.

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.

Equal Employment Opportunity

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

EEO is the Law

EEO is the law - Poster Supplement

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