Analyst I, Quality Batch Release

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

Benefits offered by this job

Health and dental benefits from day 1

401(k) with company match

Employee stock purchase plan

Job summary

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

The role involves document review, on-floor QC activities, risk identification, audits support, and Lean Six Sigma projects. A STEM degree and GMP/FDA knowledge are required, with competitive pay and benefits.

Qualifications

• Bachelor's degree in a scientific, engineering, manufacturing, or related discipline.
• Experience in regulated manufacturing such as medical device or pharma.
• Knowledge of GMP, GDP, and quality system requirements.
• Familiarity with FDA 21 CFR Part 820/211, ISO 13485, or comparable regulatory standards.
• Strong attention to detail and ability to prioritize and meet deadlines.
• Proficiency with Word, Excel, and related tools.

Responsibilities

• Review and release production and finished goods documentation.
• Conduct on-floor quality assurance activities and process monitoring.
• Partner with manufacturing and cross-functional teams to manage quality risks.
• Maintain and improve quality system processes including change controls.
• Support audits by preparing docs and addressing observations.
• Analyze quality metrics to identify process improvements.
• Contribute to Lean/Six Sigma based continuous improvement.

Skills

Attention to detail

Cross-functional collaboration

Microsoft Office

Education

Bachelor's degree in a scientific, engineering, manufacturing, or related discipline

Tools

Microsoft Office

Job description

This is whereyour work makes a difference.

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job-you will find purpose and pride.

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. For questions about this, our pay philosophy, and available benefits.

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)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. 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. For additional information regarding Baxter US Benefits.

Equal Employment Opportunity

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. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, let us know the nature of your request along with your contact information.