Senior GCP QA Auditor: Lead Audits & Compliance

ThermoFisher Scientific; Juneau (AK); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Thermo Fisher Scientific in Alaska seeks a Quality Assurance Auditor III to lead complex GCP audits and ensure regulatory compliance across programs. You will guide internal and client audits, review documentation, and mentor junior auditors while delivering high-quality audit reports.

The role requires a Bachelor's degree and 5+ years of GCP QA experience, with strong problem-solving, communication, and risk assessment skills. On-site work in a laboratory/office setting is expected.

Qualifikationen

• Bachelor's degree or equivalent required
• 5+ years' GCP QA experience or equivalent
• Experience with audits of clinical or regulatory nature

Aufgaben

• Conduct and/or lead a variety of client, internal or GCP audits and regulatory inspections as requested by senior management
• Lead directed site audits, facility, vendor and/or sub-contractor audits
• Provide GCP consultation and support to project teams and external clients
• Lead process audits and may participate as a co-auditor in more complex system audits
• Perform other types of QA audits or activities (e.g. database audits, clinical study report audits, sample results tables, process improvement)
• Contacted by others to serve as a resource to operational departments on audit or quality assurance subject matter
• Prepare and present audit findings and/or other related information at departmental, internal operations or client meetings
• Provide mentorship and guidance to junior auditors

Kenntnisse

GCP knowledge

Audits experience

Communication skills

Problem solving

Root cause analysis

Negotiation

Multitasking

Driver's license

Ausbildung

Bachelor's degree or equivalent

Jobbeschreibung

Thermo Fisher Scientific in Alaska seeks a Quality Assurance Auditor III to lead complex GCP audits and ensure regulatory compliance across programs. You will guide internal and client audits, review documentation, and mentor junior auditors while delivering high-quality audit reports.

The role requires a Bachelor's degree and 5+ years of GCP QA experience, with strong problem-solving, communication, and risk assessment skills. On-site work in a laboratory/office setting is expected.