Analyst I, Quality Batch Release

• 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.

• 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.

• 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.