Quality Assurance Specialist (GMP/Regulated Manufacturing)

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

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.