Quality Assurance Specialist – GMP & Process Improvement

Baxter Healthcare; Illinois; On-site; USD 68,000 - 94,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Paid time off 20–35 days

Job summary

Baxter Healthcare in the United States is hiring a Quality Assurance Specialist to ensure 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.

This role requires a Bachelor’s degree in a scientific/engineering discipline, GMP/GDP knowledge, and strong documentation and collaboration

Qualifications

• Bachelor's degree in a scientific, engineering, manufacturing, or related discipline, or equivalent combination of education and regulated industry experience.
• Experience in a regulated manufacturing environment (medical device/pharma/biologics/healthcare).
• Working knowledge of GMP, GDP, and quality system requirements.
• Familiarity with FDA regulations (21 CFR Part 820/211), ISO 13485, or comparable standards.
• Strong attention to detail with ability to review documentation accurately.
• Ability to prioritize work, meet deadlines, and collaborate across functions.
• Proficiency with Word, Excel, and related tools.

Responsibilities

• Review and release production and finished goods documentation for compliance.
• Conduct on-the-floor QA activities: inspections, verifications, process monitoring.
• Partner with manufacturing and cross-functional teams to identify risks and support decisions.
• Maintain and improve quality system processes, change controls, and documentation.

Skills

Attention to detail

Prioritization

Cross-functional collaboration

MS Office proficiency

Education

Bachelor's degree in science/engineering/manufacturing

Tools

Microsoft Word

Microsoft Excel

MS Office

Job description

Baxter Healthcare in the United States is hiring a Quality Assurance Specialist to ensure 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.

This role requires a Bachelor’s degree in a scientific/engineering discipline, GMP/GDP knowledge, and strong documentation and collaboration