Senior Quality Assurance Auditor

2 months ago

Markham, Ontario, Canada Everest Clinical Research Services Inc Full time

Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing a broad range of expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries.

We serve some of the most renowned companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Our organization has a strong foundation as a statistical and data management center of excellence, and we have successfully developed and established ourselves as a full-service CRO.

We are known in the industry for our high-quality deliverables, superior customer service, and flexibility in meeting clients' needs.

A dynamic organization with an entrepreneurial origin, we continue 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 team as a Senior Quality Assurance Auditor.

This position can be based in our on-site location or remotely from a home-based office.

Key Responsibilities:

• Conduct scheduled internal audits to assess compliance with applicable regulatory requirements and our 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 our governing documents according to SOPs, including entering tracking information into a database and updating records when documents are updated.

• Assist with external audits by clients and regulatory inspections.

• Independently conduct vendor qualification assessments and coordinate the assessment effort.

• Conduct employee training of QA procedures.

• Follow-up with Project Managers to ensure that study-specific training and Project Kick-off Meetings are properly conducted.

• 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.

• 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 assigned tasks over extended periods of time.

• Comprehensive skills in Microsoft Office applications.

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