Quality Assurance Specialist II

Thermo Fisher Scientific is seeking a detail-driven Quality Assurance Specialist II to join our on-site team in West Hills, Los Angeles County, supporting the production of high-quality RUO and IVD TDX HLA Typing kits and reagents in a full-time, Monday–Friday role.

About the Role

As a Quality Assurance Specialist II at Thermo Fisher Scientific, you will help safeguard product integrity across our HLA typing product lines. Working in an office and manufacturing environment, you will partner closely with cross-functional teams to ensure that validation activities, documentation, and quality processes meet the standards expected in a regulated diagnostics setting.

Key Responsibilities

• Review and assess equipment validations to confirm instruments are qualified for their intended use.
• Evaluate process validations supporting the manufacture of RUO and IVD TDX HLA typing kits and reagents.
• Administer change control activities, ensuring modifications are properly documented, justified, and approved.
• Support technical transfers between teams, sites, or processes with thorough quality oversight.
• Provide quality input on new product initiatives from early development through release.
• Uphold all Good Manufacturing Practice (GMP) requirements and applicable safety standards throughout daily operations.

Qualifications

• Hands-on familiarity with quality assurance practices in a GMP-regulated manufacturing environment.
• Working knowledge of validation concepts, including equipment and process validation review.
• Understanding of change control, technical transfer, and new product introduction workflows.
• Strong attention to detail and the documentation discipline needed for IVD and RUO product lines.
• Ability to collaborate effectively across teams while maintaining compliance and safety standards.
• Availability for a standard, on-site, full-time schedule (Monday–Friday) in West Hills.

About Thermo Fisher Scientific

Thermo Fisher Scientific is a global leader in serving science, helping customers accelerate research, solve complex analytical challenges, and improve patient health. Our West Hills team contributes to this mission by producing reliable HLA typing solutions used in research and clinical diagnostics, supported by a strong commitment to quality and safety.

How to Apply

If you are ready to advance your quality assurance career with Thermo Fisher Scientific in West Hills, Los Angeles County, we encourage you to apply. Submit your application through the official listing here: View full listing & apply.