GCP QA Auditor III: Lead Audits, Drive Compliance & Excellence

ThermoFisher Scientific; Austin (TX); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Thermo Fisher Scientific is seeking a Quality Assurance Auditor III to lead complex audits and ensure compliance with GCP guidelines and client requirements. The role involves multi-department coordination, regulatory inspections, and providing strategic audit insights to drive quality improvements.

You will mentor junior auditors, review technical documents, and present findings to management and clients. Strong communication, risk assessment, and root cause analysis skills are essential.

Qualifikationen

• Bachelor's degree or equivalent and relevant formal academic qualification.
• 5+ years’ GCP QA experience or equivalent in audits and regulatory environments.
• Equivalency accepting combination of education, training, and related experience.

Aufgaben

• Conduct and/or lead client, internal or GCP audits and regulatory inspections.
• Lead site audits, facility, vendor and subcontractor audits.
• Provide GCP consultation and support to project teams and external clients.
• Lead process audits and participate as co-auditor in complex system audits.
• Prepare and present audit findings to management and clients.
• Mentor junior auditors.

Kenntnisse

GCP audits

Audit leadership

Regulatory knowledge

Communication

Root cause analysis

Risk assessment

Negotiation

Multi-tasking

Travel readiness

Ausbildung

Bachelor's degree or equivalent

Jobbeschreibung

Thermo Fisher Scientific is seeking a Quality Assurance Auditor III to lead complex audits and ensure compliance with GCP guidelines and client requirements. The role involves multi-department coordination, regulatory inspections, and providing strategic audit insights to drive quality improvements.

You will mentor junior auditors, review technical documents, and present findings to management and clients. Strong communication, risk assessment, and root cause analysis skills are essential.