Analyst I, Quality Batch Release

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

As a Quality Assurance Specialist, you will play a critical role in ensuring compliance, product quality, and operational excellence within our manufacturing environment. You will serve as a key quality partner to manufacturing and support teams, helping maintain robust quality systems, reduce risk, and drive continuous improvement initiatives. Success in this role means balancing attention to detail with sound decision-making, enabling the organization to consistently deliver safe, high-quality products to customers and patients.

What You'll Be Doing

• Review and release production and finished goods documentation to ensure compliance with quality procedures, regulatory standards, and documentation requirements.
• Conduct on-the-floor quality assurance activities, including inspections, verifications, and process monitoring, to support product quality and manufacturing excellence.
• Partner with manufacturing and cross-functional teams to identify quality risks, resolve issues, and support timely decision-making.
• Maintain and improve quality system processes, including change controls, documentation updates, and compliance-related activities.
• Support internal and external audits by preparing documentation, addressing observations, and helping sustain inspection readiness.
• Analyze quality metrics and performance trends to identify opportunities for process improvements and operational efficiencies.
• Contribute to continuous improvement initiatives using Lean Manufacturing and Six Sigma principles to strengthen quality and business performance.

What You'll Bring

Required Qualifications

• Bachelor's degree in a scientific, engineering, manufacturing, or related discipline, or equivalent combination of education and regulated industry experience.
• Experience working within a regulated manufacturing environment such as medical device, pharmaceutical, biologics, or healthcare manufacturing.
• Working knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and applicable quality system requirements.
• Familiarity with FDA regulations, including 21 CFR Part 820 and Part 211, ISO 13485, or comparable regulatory standards.
• Strong attention to detail with the ability to review documentation accurately and consistently.
• Demonstrated ability to prioritize work, meet deadlines, and collaborate effectively across multiple functions.
• Proficiency with Microsoft Office applications including Word, Excel, and related business tools.

Preferred Qualifications

• Experience supporting quality assurance activities in a medical device or pharmaceutical manufacturing environment.
• Knowledge of change control systems, CAPA processes, deviation management, or audit support activities.
• Experience using Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.
• Previous experience delivering training, coaching colleagues, or supporting onboarding activities.
• Understanding of warehouse, quarantine, or material handling operations within a regulated environment.

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 $68,000 - $93,500 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. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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)

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