GCLP Auditor – CAP/CLIA Experience Required

This is a fully remote position, open to applicants in New Zealand, +1 more country.

📋 Description

• Develop, prepare, execute, document, and follow up on various forms of GCLP audits, including CAP/CLIA audits.

• Carry out audits based on a thorough understanding of regulatory standards and Good Clinical Laboratory Practice (GCLP).

• Implement GCLP quality assurance initiatives for pharmaceutical and biotechnology client organizations.

• Organize and oversee inspection readiness activities for GCLP process audits at sponsor and investigator locations.

• Perform GCLP mock inspections adhering to Competent Authority standards.

⛳️ Requirements

• Proven experience in conducting and leading both internal and external GCLP audits, including CAP/CLIA, for a wide range of stakeholders.

• Demonstrated experience in performing various service provider audits.

• Background in conducting GCLP systems audits.

• Experience in coordinating and managing inspection readiness activities for GCLP process audits at sponsor and investigator sites.

• In-depth knowledge of national and international GCLP regulations and guidelines.

• Willingness to travel up to 40% of the time.

• Capability to conduct remote audits.

• Bachelor's degree in Life Sciences preferred.

• Experience with conducting GCLP mock inspections to Competent Authority standards is considered a significant asset.

🏝️ Benefits

• Up to 40% travel opportunities.

• Possibility to conduct remote audits.

• Supportive and collaborative work environment.

• Encouragement for professional development.

• Chance to make a meaningful impact within the industry.

• Collaborate with esteemed life sciences companies.

• Join a passionate and cooperative team of experts.

• Work in a diverse and inclusive workplace where every voice is valued.