Analyst I, Quality Batch Release

Baxter • Hayward, CA

1d

About The Position

Baxter is hiring a quality assurance professional to support compliance, product quality, and operational excellence in a regulated manufacturing environment. The role partners with manufacturing and support teams to maintain quality systems, reduce risk, and contribute to continuous improvement, helping ensure safe, high-quality products reach customers and patients.

The position reviews and releases production and finished-goods documentation, performs on-the-floor quality activities, supports audits and quality-system processes, and uses quality data to identify improvement opportunities. The description states an estimated base salary of $68,000–$93,500 annually; discretionary bonuses may also be available. Applicants must be authorized to work for any U.S. employer; visa sponsorship is not available.

Baxter describes a comprehensive benefits package for eligible U.S. roles (except Puerto Rico), including medical and dental coverage beginning on day one, insurance coverage, retirement and financial benefits, educational assistance, paid time off, leave benefits, commuting benefits, employee discounts, employee assistance, and childcare benefits.

Requirements

• Bachelor’s degree in a scientific, engineering, manufacturing, or related discipline, or an equivalent combination of education and regulated-industry experience.
• Experience 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 United States; visa sponsorship is not available.

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 with Lean Manufacturing, Six Sigma, or other continuous-improvement methodologies.
• Previous experience delivering training, coaching colleagues, or supporting onboarding.
• Understanding of warehouse, quarantine, or material-handling operations in a regulated environment.

Responsibilities

• Review and release production and finished-goods documentation for compliance with quality procedures, regulatory standards, and documentation requirements.
• Perform 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 decisions.
• Maintain and improve quality-system processes, including change controls, documentation updates, and compliance 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 beginning on day one for eligible roles.
• 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 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 (EAP).
• Childcare benefits.
• The position may be eligible for discretionary bonuses.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level