Analyst I, Quality Batch Release
About The Position
As a Quality Assurance Specialist at Baxter, this role supports compliance, product quality, and operational excellence in a regulated manufacturing environment. It serves as a quality partner to manufacturing and support teams, helping maintain quality systems, reduce risk, and advance continuous improvement so the organization can deliver safe, high-quality products to customers and patients. The role reviews and releases production and finished-goods documentation, performs on-the-floor quality assurance activities, partners with cross-functional teams to resolve quality issues, maintains quality system processes, supports audits and inspection readiness, analyzes quality metrics, and contributes to Lean and Six Sigma improvement initiatives. The estimated base salary is $68,000–$93,500 annually, with possible discretionary bonuses. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is not available at this time.
Requirements
- Bachelor's degree in a scientific, engineering, manufacturing, or related discipline, or an equivalent combination of education and regulated-industry experience.
- Experience working in 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 and ability to review documentation accurately and consistently.
- Ability to prioritize work, meet deadlines, and collaborate effectively across multiple functions.
- Proficiency with Microsoft Office applications, including Word and Excel, and related business tools.
- Authorization to work for any employer in the U.S.; Baxter is unable to sponsor or take over sponsorship of an employment visa.
Nice To Haves
- Experience supporting quality assurance activities in medical device or pharmaceutical manufacturing.
- 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.
Responsibilities
- Review and release production and finished-goods documentation for compliance with quality procedures, regulatory standards, and documentation requirements.
- Conduct on-the-floor quality assurance activities, including inspections, verifications, and process monitoring.
- 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 sustaining inspection readiness.
- Analyze quality metrics and performance trends to identify process-improvement and operational-efficiency opportunities.
- Contribute to continuous improvement initiatives using Lean Manufacturing and Six Sigma principles.
Benefits
- Medical and dental coverage starting on day one
- Basic life, accident, short-term and long-term disability, and business travel accident insurance
- Employee Stock Purchase Plan with the ability to purchase company stock at a discount
- 401(k) Retirement Savings Plan with 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
- Childcare benefits
- Possible discretionary bonuses
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
