GCLP Auditor – CAP CLIA Experience Required

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🔥 0 minutes ago

🌐 New Zealand, United States – Remote

🇳🇿 New Zealand – Remote 🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔎 Auditor

👻 Ghost score 16%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Plan, prepare, conduct, report, and follow up on various types of GCLP audits, including CAP CLIA • Execute audits based on comprehensive understanding of regulatory requirements and Good Clinical Laboratory Practice (GCLP) • Perform GCLP quality assurance projects for pharmaceutical and biotechnology client companies • Coordinate and manage inspection preparation activities for GCLP process inspections at sponsor and investigator sites • Conduct GCLP mock inspections to Competent Authority standards

🎯 Requirements

• BSc in Life Science preferred • Experience in conducting and leading internal and external GCLP audits including CAP CLIA for a variety of stakeholders • Experience in conducting a range of service provider audits • Experience in conducting GCLP systems audits • Experience in coordinating and managing inspection preparation activities for GCLP process inspections at sponsor and investigator sites • Expert knowledge of national and international GCLP legislation and guidelines • Up to 40% travel • Ability to conduct remote audits

🏖️ Benefits

• Up to 40% travel • Ability to conduct remote audits • Supportive, collaborative environment • Professional growth encouraged • Opportunity to make a real impact across the industry • Collaborative team of experts in clinical research, pharmacovigilance, and quality consulting