Quality Associate II

Milwaukee Succeeds; Round Lake (IL); On-site; USD 88,000 - 121,000; Full time

Benefits offered by this job

Medical and dental coverage

ESPP with stock purchase at discount

401(k) with company match

Paid time off 20–35 days

Parental leave

Commuting benefits

Employee discounts

Employee Assistance Program

Job summary

Baxter seeks a Quality Investigator to lead investigations into deviations, nonconformances, complaints, and other quality events across manufacturing and quality systems. You will analyze data from manufacturing, labs, and engineering to identify facts, evaluate evidence, and develop defensible conclusions.

Collaboration with cross-functional teams drives CAPAs and product disposition decisions. Strong technical writing, project management, and knowledge of eQMS (TrackWise or similar) are

Qualifications

• Bachelor’s degree in a scientific or quality discipline or related regulated-industry experience.
• 3+ years in pharmaceutical/biotech/medical device quality operations.
• 2+ years leading investigations, deviations, CAPAs, or complaints.
• Working knowledge of cGMP, DQP, QMS, and data integrity.
• Strong ability to evaluate evidence and develop defensible conclusions.
• Excellent written communication, project management, and problem solving.

Responsibilities

• Lead quality investigations for deviations, nonconformances, complaints, and other events.
• Analyze manufacturing, lab, engineering, and quality-system data to identify facts and conclusions.
• Develop hypotheses to determine root causes and contributing factors.
• Assess impact to products, processes, data, and patients, guiding decisions.
• Collaborate with cross-functional SMEs to gather evidence and drive CAPA plans.
• Recommend CAPAs addressing root causes and long-term improvements.
• Create inspection-ready investigation reports in eQMS.

Skills

Quality investigations

Root cause analysis

cGMP compliance

Data integrity

Technical writing

Project management

Cross-functional collaboration

eQMS knowledge

Communication of risks

Education

Bachelor's in Science/Engineering/Pharma/Life Sciences

Tools

TrackWise

Microsoft Office

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.

What You’ll Be Doing

• Lead quality investigations for deviations, nonconformances, complaints, and other quality events, ensuring timely execution in accordance with risk-based quality processes and regulatory requirements.
• Analyze manufacturing, laboratory, engineering, and quality-system data to identify facts, evaluate evidence, and develop well-supported conclusions.
• Develop and test multiple hypotheses to determine direct, contributing, and root causes using proven investigation and problem-solving methodologies.
• Assess actual and potential impact to products, processes, data, and patients while supporting risk-based quality decisions and product disposition activities.
• Partner with cross-functional subject matter experts to gather evidence, resolve issues, drive alignment, and execute investigation plans.
• Recommend corrective and preventive actions (CAPAs) that address identified causes, reduce risk, and support long-term process improvement.
• Create clear, thorough, and inspection-ready investigation reports while maintaining accurate records within the electronic Quality Management System (eQMS).

What You’ll Bring

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or a related technical discipline; equivalent combinations of education and directly relevant regulated-industry experience may be considered.
• 3+ years of experience within pharmaceutical, biotechnology, medical device, manufacturing, engineering, laboratory, or Quality operations in a regulated environment.
• 2+ years of experience leading or significantly contributing to investigations, deviations, nonconformances, customer complaints, CAPAs, or related quality processes.
• Working knowledge of cGMP regulations, Good Documentation Practices, quality systems, CAPA principles, quality risk management, and data integrity requirements.
• Demonstrated ability to evaluate evidence objectively, perform root cause analysis, and develop defensible, evidence-based conclusions.
• Strong analytical thinking, technical writing, project management, facilitation, interviewing, and problem-solving skills.
• Ability to collaborate effectively across functions, influence without direct authority, manage competing priorities, and communicate risks clearly.
• Experience using Microsoft Office applications and electronic Quality Management Systems (eQMS) such as TrackWise or similar platforms.

Preferred Qualifications

• Experience supporting FDA, Health Canada, customer, or other regulatory inspections and audit activities.
• Knowledge of investigation methodologies such as 5 Whys, Fishbone/Ishikawa Analysis, Fault Tree Analysis, DMAIC, process mapping, and quality risk assessment.
• Experience utilizing data visualization, reporting, or statistical analysis tools to support quality investigations and trend analysis.
• Lean Six Sigma Green Belt certification or equivalent process improvement experience.
• ASQ certification or related quality credential.

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)

• Medical and dental coverage that starts on day one
• Insurance coverage for 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 (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays
• Paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits

For additional information regarding Baxter US Benefits, 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.

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.