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QA Auditor, Clinical Research

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Primary Location: Durham, North Carolina, United States Full time R1235147

Job description

Purpose:

A QA Auditor 2 for Customer Audits is responsible for hosting customer audits and assisting with regulatory inspections. Managing QA oversight of projects, assignments, and training. Providing consultation in interpretation of regulations, guidelines, policies, and procedures. Providing support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures. 

Summary of Responsibilities:

  • Scheduling, planning, and hosting customer audits.
  • Assisting with regulatory facility inspections by serving as a member of the QA Inspection Management Team.
  • Maintain customer audit and regulatory inspection toolboxes.
  • Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
  • Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
  • Provide consultation to customers, functional leads and monitors in interpretation of audit observations and formulation of corrective action plans.
  • Prepare, review and approve corrective action plans
  • Present educational programs and provide guidance to operational staff on compliance procedures.
  • Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.
  • Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
  • Serve as author of Quality Assurance SOPs as assigned.
  • Lead Projects.
  • Train new staff as required.

Required Knowledge, Skills and Abilities:

  • Practical experience in scheduling, planning, and hosting customer audits.
  • Thorough understanding of GCP, PV, and other relevant quality compliance requirements of major regulatory agencies (FDA, EMA, PMDA) and demonstrated experience interpreting and applying relevant regulations, laws and guidance.
  • Practical experience applying proactive quality approaches for clinical trials.

Required Education and Experience:

  • Bachelors degree in a scientific or healthcare-related field
  • Demonstrated experience scheduling, planning, and hosting customer audits
  • Minimum 2-3 years of experience in experience in clinical quality in a pharmaceutical, biotech, or other regulated industry.

  • #LI-Remote

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.

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