Staff QA Engineer - GMP & Regulatory Compliance

ThermoFisher Scientific; Greenville (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Staff QA Engineer to join our team in North Carolina. You will help ensure product quality and regulatory compliance across operations, collaborating with cross-functional teams to advance quality initiatives and support audits, CAPA, and validation activities.

The role emphasizes leadership, rigorous quality systems, and data integrity to enable customers to access safe, effective solutions globally.

Qualifications

• Strong knowledge of GMP and ISO standards in regulated environments.
• Experience conducting internal and external audits including regulatory inspections.
• Expertise in CAPA, change control, document control, and risk management.
• Proficiency in quality tools (FMEA, RCA, statistical analysis).
• Experience with IQ/OQ/PQ and process validation.
• Travel up to 25%.
• Excellent written and verbal communication.

Responsibilities

• Lead quality assurance activities across regulatory compliance initiatives.
• Coordinate internal/external audits and regulatory inspections.
• Support validation activities (IQ/OQ/PQ) and process validation.
• Mentor cross-functional teams to uphold a culture of quality.

Skills

GMP knowledge

ISO 9001/13485 knowledge

Regulatory inspections experience

CAPA & Change control

FMEA & RCA

Process validation

Cross-functional leadership

Data integrity awareness

Document control

Audits experience

Quality management software

Education

Advanced Degree + 6 years QA exp in regulated environments

Bachelor's Degree + 8 years QA exp

ASQ CQE

ASQ CQA

Tools

TrackWise

SAP

Job description

Thermo Fisher Scientific is seeking a Staff QA Engineer to join our team in North Carolina. You will help ensure product quality and regulatory compliance across operations, collaborating with cross-functional teams to advance quality initiatives and support audits, CAPA, and validation activities.

The role emphasizes leadership, rigorous quality systems, and data integrity to enable customers to access safe, effective solutions globally.