Quality Assurance Auditor I

This is a fully remote position, open to applicants in Romania.

📋 Description

• Conduct scheduled internal audits to evaluate compliance with relevant regulatory standards and Everest Standard Operating Procedures (SOPs).

• Timely document and report findings from audits.

• Ensure follow-up on compliance issues until they are resolved.

• Maintain governing documents in accordance with SOPs, including entering tracking information into a database and updating records as necessary.

• Report and track outstanding obligations for SOP reviews.

• Provide assistance during external client audits and regulatory inspections.

• Support employee training initiatives related to QA procedures.

• Aid in the investigation of non-conformities.

• Engage in research and participate in relevant training or association activities focused on industry best practices in QC and QA.

⛳️ Requirements

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

• Certification in QA and auditing concepts is preferred.

• Minimum of 3 years’ experience in a clinical research environment.

• At least 1 year of experience in auditing.

• Familiarity with clinical trial processes and procedures.

• Understanding of pharmaceutical industry regulatory requirements, including those from the FDA, Health Canada, and the European Medicines Agency.

• Thorough knowledge of ICH and GCP guidelines.

• Awareness of QC and QA processes and procedures.

• Understanding of procedural document management, auditing, and training concepts.

• Excellent analytical and creative problem-solving abilities.

• Strong conflict resolution skills.

• Dedication to quality and continuous process improvement.

• Capability to deliver quality outputs promptly.

• Proficient oral and written communication skills with personnel across all professional and administrative levels.

• Detail-oriented with a keen eye for inconsistencies.

• Well-organized with strong multitasking capabilities.

• Ability to maintain focus on assigned tasks over extended periods.

• Proficient skills in Microsoft Office applications.

🏝️ Benefits

• Remote work arrangement.

• Equal opportunity employer.

• Accommodations for candidates with disabilities during recruitment and selection available upon request.