Quality Assurance Auditor I - Hybrid/Remote-Ready

Everest-Clinical-Research; Warszawa; Hybrid; PLN 140,000 - 190,000; Full time

Job summary

Everest Clinical Research in Warsaw, Poland, offers a Quality Assurance Auditor I position with hybrid work options. The role focuses on conducting internal audits, maintaining SOPs, and supporting external audits to ensure regulatory compliance.

You will train staff on QA procedures and investigate non-conformities while staying current with industry best practices and regulatory guidelines.

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 procedures.
• Knowledge of pharmaceutical industry regulatory requirements (FDA, Health Canada, EMA, etc).
• ICH and GCP knowledge.
• QA/QC processes and training concepts.

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 governing documents per SOPs and update tracking databases.
• Assist with external audits by clients and regulatory inspections.
• Assist in QA staff training on QA procedures.
• Assist with investigation of non-conformities.
• Keep abreast of best practices in QC and QA through training and associations.

Skills

Analytical skills

Creative problem solving

Verbal & written communication

Detail-oriented

Organizational & multi-tasking

Microsoft Office

Education

Bachelor's degree in health science/physics/biology/mathematics

QA/auditing concepts certificate (preferred)

Tools

Microsoft Office

Job description

Everest Clinical Research in Warsaw, Poland, offers a Quality Assurance Auditor I position with hybrid work options. The role focuses on conducting internal audits, maintaining SOPs, and supporting external audits to ensure regulatory compliance.

You will train staff on QA procedures and investigate non-conformities while staying current with industry best practices and regulatory guidelines.