Quality Associate II

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

Benefits offered by this job

Medical and dental coverage starting 1

401(k) Retirement Savings Plan (RSP)

Employee Stock Purchase Plan (ESPP)

Job summary

Baxter is hiring for a Quality Assurance role in the United States. You will lead quality investigations, support CAPA and nonconformances, and partner with Manufacturing, Engineering, Regulatory Affairs, and QC to uphold FDA/ISO quality standards.

The position emphasizes data-driven quality improvements, inspection readiness, and clear, compliant documentation across QMS processes. A strong cross-functional team player mindset is essential.

Qualifications

• Minimum 3 years of experience in QA, Quality Systems, Quality Engineering, or Compliance in regulated pharma/biotech/medical device.
• Hands-on experience with change control, CAPA, complaints, nonconformance, deviations, or audit support.
• Strong knowledge of FDA/ISO quality regs and GMP requirements.

Responsibilities

• Lead routine quality investigations using root cause analysis and develop corrective actions.
• Assess changes for regulatory and quality impact and coordinate cross-functional reviews.
• Prepare and report QMS metrics and trend analyses; support management review materials.

Skills

Quality systems

Cross-functional collaboration

Problem solving

Regulatory awareness

Technical writing

Education

Bachelor's degree in science/engineering/pharmacy/life sciences/quality

Tools

TrackWise

Veeva

MasterControl

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

This is where your creativity addresses challenges

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

You will support complex QMS processes and serve as a knowledgeable resource for change control, CAPA, complaints, and nonconformance records. In this role you will lead routine quality investigations, contribute to metrics analysis and trend reporting, and support inspection readiness.

What you'll be doing

• Lead routine quality investigations including root cause analysis using structured tools (5 Whys, Fishbone) and develop effective corrective/preventive actions.
• Assess proposed changes for regulatory, product quality, and compliance impact; coordinate cross-functional review and approval.
• Prepare, analyze, and report QMS metrics for assigned processes; identify adverse trends and recommend corrective actions.
• Support preparation of management review data packages, dashboards, and trend reports for assigned QMS elements.
• Write, review, and revise SOPs, work instructions, and quality system documentation to ensure compliance with regulatory requirements.
• Serve as a resource and subject matter expert for assigned QMS processes, providing guidance to process users and record owners.
• Support internal audits, corporate audits, and regulatory inspections by preparing records, responding to requests, and participating in front-room activities.
• Lead or participate in continuous improvement initiatives to enhance QMS efficiency, reduce cycle times, and improve right-first-time documentation.
• Partner cross-functionally with Manufacturing, Engineering, QC, Regulatory Affairs, and other stakeholders to drive timely resolution of quality system issues.
• Maintain inspection-ready records in Baxter's eQMS platforms; ensure data integrity and traceability.
• Escalate significant quality issues, overdue commitments, or potential compliance risks through established governance processes.

What you'll bring

• Candidate must not be allergic to Penicillins or Cephalosporins.
• Bachelor's degree in science, engineering, pharmacy, life sciences, quality, or related technical discipline required.
• Minimum of 3 years of experience in Quality Assurance, Quality Systems, Quality Engineering, or Compliance in a regulated pharmaceutical, biotech, or medical device environment.
• Hands-on experience with multiple QMS elements: change control, CAPA, complaints, nonconformance, deviations, or audit support.
• Solid knowledge of FDA regulations (21 CFR 210/211, 21 CFR Part 820), ISO 13485, cGMP, and quality management system requirements.
• Experience with root cause analysis tools (5 Whys, Fishbone/Ishikawa, fault tree analysis) and corrective action development.
• Proficiency with eQMS platforms such as TrackWise, Veeva, MasterControl, or equivalent.
• Strong technical writing skills with demonstrated ability to prepare clear, inspection-ready quality documentation.
• Good analytical, problem-solving, and critical thinking skills.
• Strong communication and cross-functional collaboration skills.
• Ability to manage multiple complex records and projects with limited supervision.
• Experience preparing quality metrics, trend reports, or management review materials preferred.
• Experience supporting FDA, ISO, or other regulatory inspections preferred.
• Experience in pharmaceutical or sterile manufacturing environment preferred

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 to $121,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon 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.

• Medical and dental coverage that start 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

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.