Quality Associate II
About The Position
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 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. 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.
Requirements
- 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.
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
