Senior Quality Engineer - GMP & Compliance

Regulatory Jobs; St. Louis (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Quality Engineer III to support quality assurance across clinical and commercial manufacturing programs. The role collaborates with cross-functional teams to ensure products meet regulatory requirements and quality standards.

This individual contributor position emphasizes investigation of quality events, process improvements, and support for technology transfer and regulatory inspections.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or another scientific or technical discipline.

Responsibilities

• Support QA activities for clinical and commercial manufacturing programs.
• Partner with Manufacturing, Operations, Engineering, Validation, Regulatory Affairs, and other teams to ensure GMP compliance.
• Review and approve GMP documentation including batch records, deviations, CAPAs, and validation documents.
• Lead quality investigations, perform root cause analyses, and support corrective and preventive actions.

Skills

Quality assurance

Regulatory compliance

Root cause analysis

Statistical analysis

Project management

Communication

Education

Bachelor's degree in engineering, life sciences, chemistry or related field

Advanced degree (preferred)

Tools

Quality Management System (QMS)

Microsoft Office

Job description

Thermo Fisher Scientific is seeking a Quality Engineer III to support quality assurance across clinical and commercial manufacturing programs. The role collaborates with cross-functional teams to ensure products meet regulatory requirements and quality standards.

This individual contributor position emphasizes investigation of quality events, process improvements, and support for technology transfer and regulatory inspections.