Sr. Auditor, Quality Assurance
Senior Auditor for Quality Assurance - Perm - Durham, NC
Proclinical is currently recruiting for a dedicated Senior Auditor for Quality Assurance to join a CRO. This role focuses on maintaining and enhancing quality initiatives within the company, including SOPs and training, computer systems validation, and Quality Management System.
Primary Responsibilities:
The successful candidate will have a strong understanding of Good Clinical Practices (GCP), Good Documentation Practices (GDP), and other applicable regulatory and ethical requirements.
Skills & Requirements:
- Bachelor's degree or equivalent in a scientific, management, or related discipline.
- Experience in quality assurance, quality control, and/or validation.
- Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice, Title 21 of the Code of Federal Regulations, and good industry practices involving Quality.
- Excellent presentation skills.
- Proficiency in English.
The Senior Auditor for Quality Assurance's responsibilities will be:
- Maintain the Quality Management System (QMS) in line with current GCP, GDP, and other relevant regulations.
- Generate, review, and implement SOPs and associated training.
- Conduct vendor and internal audits, and essential document audits.
- Generate, approve, and implement external and internal audit plans and processes.
- Coordinate and host sponsor audits; respond to audit observations.
- Support company regulatory agency inspections.
- Track GCP quality system metrics such as quality events, CAPAs, and deviations.
- Support and adhere to all aspects of the company's Quality System.
- Comply with the company's data integrity and business ethics requirements.
- Lead Quality Assurance in support of computer system validation activities.
- Assist Department leadership with administrative and management functions as required.
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at Write an email
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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