Senior Quality Assurance Auditor I

6 days ago

Markham, Ontario, Canada Everest Clinical Research Full time

About Us

Everest Clinical Research 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 world's most renowned companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Our Mission

Our mission is to deliver high-quality clinical research services that meet the evolving needs of our clients. We are committed to excellence, innovation, and customer satisfaction.

Job Summary

We are seeking a highly experienced and skilled Senior Quality Assurance Auditor I to join our team. This role will be responsible for ensuring the quality and integrity of our clinical research services.

Key Responsibilities

  • Complete scheduled internal audits to assess compliance with applicable regulatory requirements and company 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 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 as needed.
  • Conduct employee training of QA procedures.
  • Follow-up with Project Managers or Project Oversight personnel to ensure that study-specific training and Project Kick-off Meetings are properly conducted by project teams.
  • Follow-up on industry best 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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