Quality Assurance Specialist - GMP & Process Improvement

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

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.