Senior Quality Engineer - GMP & Compliance

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

Job summary

Thermo Fisher Scientific in the United States is seeking a Quality Engineer III to support quality assurance for clinical and commercial manufacturing programs. You will partner with cross-functional teams to ensure products meet regulatory requirements and quality standards.

You will review GMP documentation, lead investigations, implement CAPAs, and drive continuous improvement across manufacturing, validation, and regulatory affairs.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical discipline.
• Advanced degree with 3+ years of experience, or bachelor's with 5+ years in quality assurance within a regulated pharmaceutical/biotech/medical device manufacturing environment.
• Experience supporting GMP quality systems and regulatory compliance.

Responsibilities

• Support quality assurance 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 (batch records, deviations, change controls, CAPAs, validation).
• Lead quality investigations and perform root cause analyses; implement CAPAs.
• Evaluate quality system data to identify trends and drive improvements.
• Participate in risk assessments and quality planning for lifecycle management.
• Support technology transfer and new manufacturing processes.
• Participate in internal/customer/regulatory audits and inspections.
• Contribute to continuous improvement of quality systems and operations.
• Maintain training requirements and ensure GMP compliance.

Skills

Quality Assurance

GMP Compliance

CAPA Management

Deviation Investigations

Regulatory Knowledge

Root Cause Analysis

Data Analysis

Project Management

Communication Skills

Attention to Detail

Education

Bachelor's degree in Engineering/Life Sciences

Tools

QMS Software

Job description

Thermo Fisher Scientific in the United States is seeking a Quality Engineer III to support quality assurance for clinical and commercial manufacturing programs. You will partner with cross-functional teams to ensure products meet regulatory requirements and quality standards.

You will review GMP documentation, lead investigations, implement CAPAs, and drive continuous improvement across manufacturing, validation, and regulatory affairs.