Analyst I, Quality Batch Release

Zvh; Hayward, Winton (CA, CA); On-site; USD 68,000 - 94,000; Full time

Benefits offered by this job

Health and dental insurance from day1

401(k) plan with company match

Employee stock purchase plan (ESPP)

Job summary

Baxter in California is seeking a Quality Assurance Specialist to uphold compliance, product quality, and operational excellence in our manufacturing environment. You will partner with manufacturing and support teams to maintain robust quality systems, reduce risk, and drive continuous improvement.

The role emphasizes attention to detail and sound decision-making to ensure safe, high-quality products for customers and patients.

Qualifications

• Bachelor's degree in a scientific, engineering, manufacturing, or related discipline, or equivalent education/experience.
• Experience in regulated manufacturing environments such as medical device or pharmaceutical.
• Knowledge of GMP, GDP, and quality system requirements.
• Familiarity with FDA 21 CFR Part 820/211 and ISO 13485 or equivalents.
• Strong attention to detail with reliable documentation review.
• Ability to prioritize, meet deadlines, and collaborate across functions.
• Proficiency with Microsoft Office applications including Word and Excel.

Responsibilities

• Review and release production and finished goods documentation for compliance and quality.
• Conduct on-floor QA activities, including inspections and process monitoring.
• Partner with manufacturing to identify risks, resolve issues, support timely decisions.
• Maintain and improve quality system processes, change controls, and documentation updates.
• Support audits by preparing docs, addressing observations, and sustaining inspection readiness.
• Analyze quality metrics to identify opportunities for process improvements.
• Contribute to continuous improvement using Lean Six Sigma principles.

Skills

Attention to detail

Cross-functional collaboration

Decision-making

Microsoft Office

Education

Bachelor's degree in a scientific/engineering/manufacturing discipline

Tools

Microsoft Word

Microsoft Excel

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. 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‑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.

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)

• Our health and well‑being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short‑term and long‑term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time‑off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.
• Join us and enjoy the competitive compensation and benefits we offer to our employees.

Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.