[Hiring] Quality Assurance Auditor I @Everest Clinical Research

Role Description

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Quality Assurance Auditor I, working remotely in Romania.

• Complete scheduled internal audits to assess compliance with applicable regulatory requirements and Everest Standard Operating Procedures (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, but not limited to:
  • Entering the governing document tracking information into a database.
  • Updating database records when governing documents are updated.
  • Reporting and following-up on outstanding SOP review obligations.
• 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 working practices in quality control (QC) and QA by researching and participating in relevant training and/or association activities.

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 for differing governing bodies such as FDA, Health Canada, European Medicines Agency, etc.
• A comprehensive knowledge of ICH and GCP guidelines.
• Knowledge of QC and QA processes and procedures, procedural document management, auditing, and training concepts.
• Excellent analytical and creative problem-solving skills.
• Solid conflict resolution skills.
• Commitment to quality and process improvement.
• Ability to provide timely quality deliverables.
• Effective communication skills, orally and in writing, with personnel at all professional and administrative levels.
• Detail-oriented with exceptional ability to notice inconsistencies.
• Well organized with strong multi-tasking skills.
• Ability to concentrate on the assigned tasks over extended periods of time.
• Comprehensive skills in Microsoft Office applications.

Company Description