Analyst I, Quality Batch Release
Baxter International Inc.
Summary
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.
Job description
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.
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
- 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.
Requirements
- 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
Benefits
- Medical & Dental Coverage
- Life Insurance
- Accident Insurance
- Short-Term Disability
- Long-Term Disability
- Business Travel Accident Insurance
- Employee Stock Purchase Plan
- 401(k) Matching
- Flexible Spending Accounts
- Educational Assistance
- Paid Holidays
- Paid Time Off
- Family & Medical Leave
- Paid Parental Leave
- Commuting Benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare Benefits
- Discretionary Bonuses
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.