[Hiring] Senior Quality Assurance Auditor @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 Senior QA Auditor for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Responsibilities Include:

• 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.
• Lead corrective and preventative actions investigations and follow-up on compliance issues until resolution.
• Maintain the company’s governing documents according to SOPs including, but not limited to, entering the governing document tracking information into a database, updating database records when governing documents are updated, and reporting and following-up on outstanding SOP review obligations.
• Assist with external audits by clients and regulatory inspections.
• Independently conduct vendor qualification assessments. Coordinate the assessment effort and follow up on observations as needed.
• Conduct employee training of QA procedures.
• Follow up with Project Managers or Project Oversight personnel to ensure that study-specific training, Project Kick-off Meeting (including study-specific training components), or training of Sponsor specific requirements (such as Sponsor-specific serious adverse event handling procedures, etc.) are properly conducted by project teams.
• 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.
• Certification as a quality auditor from the American Society of Quality (ASQ), ISO, or equivalent is preferred.
• At least 6 years of QA experience in a clinical research capacity. Significant contribution, outstanding and sustained performance in a non-QA role may be used in lieu of the requirement on the number of years of relevant QA experience.
• At least 1 year experience with participation in preparations/hosting regulatory inspections is preferred.
• 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.

Benefits

• Robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage.
• Life & AD&D insurance.
• Short- and long-term disability.
• Tuition reimbursement.
• Fitness reimbursement.
• Employee assistance program (EAP).
• Pension plan.
• Generous paid time off and sick leave.
• Opportunity to earn a performance-based bonus.