Senior Quality Assurance Auditor I
1 week ago
About Everest Clinical Research
Everest Clinical Research 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 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.
With a strong foundation as a statistical and data management center of excellence, Everest has successfully developed and established itself as a full-service CRO. Our headquarters are located in a major Canadian city, with additional sites in the United States and Asia.
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.
Our Commitment to Quality
Quality is our backbone, and customer-focus is our tradition. We are committed to delivering exceptional results and exceeding our clients' expectations.
About the Role
We are seeking a highly skilled 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:
- Complete 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 teams to ensure that study-specific training and project kick-off meetings are properly conducted.
- 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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