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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 wide range of expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries.

We are a dynamic organization with a strong foundation in statistical and data management, and we continue to experience exceptional growth and success.

Our company is known for its high-quality deliverables, superior customer service, and flexibility in meeting clients' needs.

We are seeking a committed, creative, and experienced individual to join our team as a Senior Quality Assurance Auditor I.

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

Responsibilities:

• Conduct 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.

• Assist with external audits by clients and regulatory inspections.

• Independently conduct vendor qualification assessments.

• 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 practices in quality control and quality assurance.

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 regulatory inspections.

• Knowledge of clinical trial processes and procedures.

• Knowledge of pharmaceutical industry regulatory requirements.

• A comprehensive knowledge of ICH and GCP guidelines.

• Knowledge of quality control and quality assurance processes and procedures.

• 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.

• 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.