Senior Quality Assurance Auditor I
4 days ago
Everest Clinical Research Services Inc is seeking a highly skilled and experienced Senior Quality Assurance Auditor I to join our team. As a Senior Quality Assurance Auditor I, you will be responsible for ensuring the quality and integrity of our clinical research services.
Responsibilities:- Conduct 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.
- Assist with external audits by clients and regulatory inspections.
- 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 is properly conducted by project teams.
- Follow-up on industry best working practices in quality control (QC) and QA.
- 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.
- 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.
We offer a dynamic and entrepreneurial work environment with opportunities for growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.
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