GCLP Auditor (Freelance) CAP/CLIA Expert

Ergomed Group; Raleigh, Northern (NC, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Ergomed Group is seeking a GCLP Auditor with CAP/CLIA experience. The role supports GCP Compliance and involves planning, conducting, and reporting GCLP audits for pharmaceutical/biotechnology clients. Remote audits and up to 40% travel are expected.

The ideal candidate has a Life Science background, leads internal and external audits, and can coordinate inspection readiness for sponsor and site inspections. This is a full-time role based in Raleigh, NC.

Qualifications

• GCLP audits leadership and execution
• Experience with CAP/CLIA audits
• Strong regulatory and quality systems understanding

Responsibilities

• Plan, prepare, conduct, report and follow up GCLP audits (CAP/CLIA)
• Coordinate and manage inspection preparation activities
• Perform GCLP QA projects for clients in pharma/biotech
• Conduct remote audits as needed

Skills

GCLP audits

Audit leadership

Regulatory knowledge

Education

BSc Life Science

Job description

Ergomed Group is seeking a GCLP Auditor with CAP/CLIA experience. The role supports GCP Compliance and involves planning, conducting, and reporting GCLP audits for pharmaceutical/biotechnology clients. Remote audits and up to 40% travel are expected.

The ideal candidate has a Life Science background, leads internal and external audits, and can coordinate inspection readiness for sponsor and site inspections. This is a full-time role based in Raleigh, NC.