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Senior Auditor for Quality Assurance

2 months ago

Durham, North Carolina, United States Proclinical Staffing Full time
Senior Auditor for Quality Assurance

Proclinical Staffing 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.

Key Responsibilities:
  • 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.
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.

Proclinical Staffing 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.