Senior Quality Assurance Auditor I

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success, we are seeking a committed, creative and experienced individual to join our winning team as Senior Quality Assurance Auditor I. This position can be based in our Markham, Ontario on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Responsibilities:

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.

Requirements:

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

Certification as a quality auditor (ASQ, ISO, or equivalent)

At least 6 years’ experience in a clinical research capacity.

At least 6 years auditing experience.

At least 1 year experience with participation in preparations/hosting regulatory inspections.

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, and 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.