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GCP Auditor

Newark Metro Area, NJ

Posted: 04/01/2019 Job Type: Scientific Job Number: JN -042019-24466
  • GCP Auditor
  • Bachelors or advanced degree
  • At least seven (7) years experience as a QA Auditor of the drug development process
  • In-depth experience with Good Clinical Practices (e.g., leading GCP audits and/or training staff in GCPs) is required
  • Comprehensive understanding of FDA regulations; knowledge of ICH guidance is required
  • Excellent interpersonal and communication skills; ability to build effective relationships within a team/collaborative environment, while demonstrating a high level of professionalism
  • Good written communications skills, including SOP/other technical writing
  • Able to travel as required within a global work environment (approximately 10%)
  • Prepares audit plans for clinical and other projects as applicable
  • Liaises with relevant parties to arrange audits or reviews required by QA audit plans
  • Performs audits of internal systems
  • Prepares reports of audits performed, per SOP(s) timelines
  • Follows up on audit observations to agreed conclusions
  • Provides audit certificates for relevant audits
  • Distributes relevant audit reports and documents in accordance with QA Policy
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