GCP QA Clinical Auditor II

Thermo Fisher Scientific

New

Mid 🇬🇧 English

Root cause analysis

Job description

About the role

Thermo Fisher Scientific is seeking a Quality Assurance Auditor II to lead and conduct GCP and other clinical audits, ensuring regulatory compliance and high quality standards across client and internal projects.

Key responsibilities

Conduct and lead client, internal, GCP, and regulatory inspections, including site, facility, vendor, and subcontractor audits.
Provide GCP consultation and support to project teams and external clients, and present audit findings at departmental or client meetings.
Perform database, clinical study report, and process improvement audits, and serve as a resource on audit and quality assurance topics.

Required profile

Bachelor's degree or equivalent with at least 2 years of QA experience.
Thorough knowledge of Good Clinical Practice (GCP) and regional research regulations.
Excellent oral and written communication, strong problem‑solving, risk assessment, and root‑cause analysis abilities.

Required skills

Good Clinical Practice (GCP) auditing
Regulatory audit execution
Root cause analysis

Questions fréquentes

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Published 12 hours ago

Expires 1 month from now

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