Quality Assurance Auditor I

About the role

Everest Clinical Research is seeking a Quality Assurance Auditor I to join its team in Sofia, Bulgaria, or work remotely. The role focuses on ensuring compliance with regulatory standards and internal SOPs across clinical research projects.

Key responsibilities

• Conduct scheduled internal audits to evaluate adherence to regulatory requirements and Everest SOPs.
• Document audit findings promptly and follow up on all compliance issues until resolution.
• Maintain governing documents, update tracking databases, and monitor SOP review obligations.
• Support external client audits and regulatory inspections.
• Assist in training staff on QA procedures and investigate non‑conformities.

Required profile

• Bachelor’s degree in health science, physics, biology, or mathematics.
• Minimum three years experience in clinical research, including at least one year in auditing.
• Strong knowledge of FDA, Health Canada, EMA regulations and ICH/GCP guidelines.
• Excellent analytical, problem‑solving and conflict‑resolution abilities.

Required skills

• Proficiency with Microsoft Office applications (Excel, Word, PowerPoint).
• Experience with database entry and management for document tracking.