Remote Quality Assurance Auditor I – Clinical Compliance

Everest Clinical Research Corporation; Warszawa; Hybrid; PLN 70,000 - 100,000; Full time

Job summary

Everest Clinical Research Corporation in Warsaw, Poland, is seeking a Quality Assurance Auditor I. The role requires a bachelor’s degree in health science, physics, biology, or mathematics, and at least 1 year of auditing experience to ensure compliance with ICH/GCP, FDA, and other regulatory requirements.

Responsibilities include conducting scheduled internal audits, documenting findings, following up on issues, maintaining governing documents, and assisting with external audits and QA

Qualifications

• Bachelor's degree in health science, physics, biology, or mathematics.
• Certificate in QA and 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 regulatory requirements (ICH, GCP, FDA, etc.).

Responsibilities

• Complete scheduled internal audits to assess compliance with applicable regulatory requirements and Everest SOPs.
• Document and report audit findings in a timely manner.
• Follow-up on all compliance issues until resolution.
• Maintain the company’s governing documents according to the SOPs, including tracking and updating documents.
• Assist with external audits by clients and regulatory inspections.
• Assist in the employee training of QA procedures.
• Assist with the investigation of non-conformities.
• Follow-up on industry best practices in QC/QA by researching and participating in training and association activities.

Skills

Analytical skills

Problem solving

Communication skills

Detail-oriented

Education

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

Tools

Microsoft Office

Job description

Everest Clinical Research Corporation in Warsaw, Poland, is seeking a Quality Assurance Auditor I. The role requires a bachelor’s degree in health science, physics, biology, or mathematics, and at least 1 year of auditing experience to ensure compliance with ICH/GCP, FDA, and other regulatory requirements.

Responsibilities include conducting scheduled internal audits, documenting findings, following up on issues, maintaining governing documents, and assisting with external audits and QA