Remote Quality Assurance Auditor I – Clinical Research

Everest New Logo; United States; Remote; USD 14,000 - 20,000; Full time

Job summary

Everest Clinical Research, a leading CRO, seeks a Quality Assurance Auditor I for a remote position based in Romania. The role focuses on internal audits, regulatory compliance, and maintaining quality SOPs across processes.

Ideal candidates have a health science-related degree, 1+ year auditing experience, and strong knowledge of ICH/GCP guidelines. The company emphasizes quality, client service, and ongoing professional development.

Qualifications

• Bachelor’s degree in health science, physics, biology, or mathematics.
• Certificate in QA auditing concepts (preferred).
• At least 3 years’ of experience in a clinical research capacity.
• At least 1 year of auditing experience.
• Knowledge of clinical trial processes and procedures.
• Knowledge of pharmaceutical industry regulatory requirements (FDA, Health Canada, EMA).
• I CH and GCP guidelines knowledge.
• Excellent analytical and creative problem-solving skills.
• Detail-oriented with strong organizational skills.

Responsibilities

• Complete scheduled internal audits to assess compliance with regulatory requirements and Everest SOPs.
• Document and report audit findings in a timely manner.
• Follow-up on all compliance issues until resolution.
• Maintain governing documents according to SOPs and update tracking databases.
• Assist with external audits by clients and regulatory inspections.
• Assist in traineeQA procedures.
• Investigate non-conformities and drive corrective actions.
• Stay updated on best QA practices through training and industry activities.

Skills

Analytical thinking

Problem solving

Communication skills

Detail-oriented

Multitasking

Education

Bachelor’s degree in health science, physics, biology, or mathematics

Certificate in QA auditing concepts

Tools

Microsoft Office

Job description

Everest Clinical Research, a leading CRO, seeks a Quality Assurance Auditor I for a remote position based in Romania. The role focuses on internal audits, regulatory compliance, and maintaining quality SOPs across processes.

Ideal candidates have a health science-related degree, 1+ year auditing experience, and strong knowledge of ICH/GCP guidelines. The company emphasizes quality, client service, and ongoing professional development.