Quality Associate II (Audit)

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

Job summary

Baxter International Inc. seeks a Quality Associate II within the Quality organization to uphold audit quality systems and regulatory compliance. You will manage internal audits, CAPA, inspections readiness, and mentor junior staff while driving continuous improvement.

The role emphasizes GMP knowledge, strong analytical skills, and the ability to collaborate across plants and offices worldwide to ensure product safety and regulatory adherence. Applicants must be authorized to work in the U.S.

Qualifications

• BS in business or science or equivalent degree.
• Minimum 3 years experience in Quality with a medical device / Pharma company or other similarly regulated industry.
• Minimum 3 years of related quality auditing experience in cGMP environments; previous internal or external auditing experience required.
• Extensive working knowledge of applicable quality and regulatory standards and regulations.
• Excellent communication skills – both written and oral – with ability to present to management.
• Must demonstrate sound judgment and analytical skills to enable assessment of risk.
• Expertise in GMP regulations and regulatory inspection processes.
• Strong organizational skills with ability to lead multiple complex projects.
• Proficiency in quality software systems (e.g., TrackWise) and MS Office applications.
• Resourceful, self-reliant, self-motivated, and confident.
• General knowledge of Lean Six Sigma and other continuous improvement tools preferred.

Responsibilities

• Maintains Compliance Audit Quality Systems in accordance with applicable regulatory requirements.
• Manages the tracking, reporting, positioning, adequacy of actions, verification, closeout, and trending of all corrective and preventive actions for audits performed.
• Prepares for and conducts internal and supplier audits by researching background information and developing assessment strategy; collects and analyzes objective evidence regarding issues and risks.
• Reports audit/inspection findings to management and evaluates audit responses, CAPA plans, and CAPA objective evidence for adequacy, including root cause determination and timeliness; escalates issues to management as appropriate.
• Manages audit files through the process to closure and performs follow-up audits to confirm CAPA effectiveness.
• Coordinates and manages state licensing program.
• Leads regulatory intelligence activities including analysis and distribution of FDA guidance, warning letters, consent decrees, and industry publications to relevant stakeholders.
• Supports external regulatory inspections including back room management, document retrieval, and commitment tracking through closure. May serve as front room host/table lead.
• Prepares management reports depicting compliance trends for Management Review purposes.
• Mentors and trains Quality Compliance Associates I and Technicians on audit methodology and compliance procedures.
• Participates in continuous improvement initiatives and quality system enhancement projects.
• Supports customer compliance activities including customer audits and customer regulatory information requests.

Skills

Audit experience

GMP knowledge

Communication skills

Leadership

Education

BS in business or science or equivalent degree

ASQ CQA certification

Tools

TrackWise

MS Office

Job description

This is where your 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.

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Quality Associate II, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

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 independently manage compliance audit processes and serve as a knowledgeable resource for internal audits, external inspection support, state licensing, and regulatory intelligence activities. In this role you will lead routine compliance investigations, contribute to metrics analysis and trend reporting, and support inspection readiness while mentoring junior team members on audit methodology and compliance expectations.

What you'll be doing

• Maintains Compliance Audit Quality Systems in accordance with applicable regulatory requirements.
• Manages the tracking, reporting, positioning, adequacy of actions, verification, closeout, and trending of all corrective and preventive actions for audits performed.
• Prepares for and conducts internal and supplier audits by researching background information and developing assessment strategy; collects and analyzes objective evidence regarding issues and risks.
• Reports audit/inspection findings to management and evaluates audit responses, CAPA plans, and CAPA objective evidence for adequacy, including root cause determination and timeliness; escalates issues to management as appropriate.
• Manages audit files through the process to closure and performs follow-up audits to confirm CAPA effectiveness.
• Coordinates and manages state licensing program.
• Leads regulatory intelligence activities including analysis and distribution of FDA guidance, warning letters, consent decrees, and industry publications to relevant stakeholders.
• Supports external regulatory inspections including back room management, document retrieval, and commitment tracking through closure. May serve as front room host/table lead.
• Prepares management reports depicting compliance trends for Management Review purposes.
• Mentors and trains Quality Compliance Associates I and Technicians on audit methodology and compliance procedures.
• Participates in continuous improvement initiatives and quality system enhancement projects.
• Supports customer compliance activities including customer audits and customer regulatory information requests.

What you'll bring

• Candidate must not be allergic to Penicillins or Cephalosporins.
• BS in business or science or equivalent degree.
• Minimum 3 years experience in Quality with a medical device / Pharma company or other similarly regulated industry.
• Minimum 3 years of related quality auditing experience in cGMP environments; previous internal or external auditing experience required.
• ASQ CQA and/or other auditor accreditation strongly preferred.
• Extensive working knowledge of applicable quality and regulatory standards and regulations.
• Excellent communication skills – both written and oral – with ability to present to management.
• Must demonstrate sound judgment and analytical skills to enable assessment of risk.
• Expertise in GMP regulations and regulatory inspection processes.
• Strong organizational skills with ability to lead multiple complex projects.
• Proficiency in quality software systems (e.g., TrackWise) and MS Office applications.
• Resourceful, self-reliant, self-motivated, and confident.
• General knowledge of Lean Six Sigma and other continuous improvement tools 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 the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based 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. 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.

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

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