Quality Assurance/ Validation Experience/ Drug Safety Associate - Princeton, NJ

12 months+

  • QA review and approval of related transition change tickets. Ensure any deviations are documented, remediated, and closed.
  • Track and ensure all assets have a final disposition. Ensure the qualification of migration software or applications used to move GxP applications.
  • Ensure qualification documentation is efficiently managed and available for inspection.
  • Participate in status calls representing IT Quality Management. Serve as a qualification subject matter expert on the transition project.
  • Maintains close communication with stakeholders and team members to keep apprised of project status and timelines.
  • Reports project status to management. Assist in the preparation of summary reports


  • Degree in computer science, information technology, life science or 5 years-experience in software quality assurance in the life sciences industry.
  • Technically conversant in concepts and techniques related to servers, databases & storage devices.
  • Working knowledge of GAMP5 concepts, 21 CFR Part 11 and ITIL.
  • Must have change management experience, preferably ServiceNow change management experience.
  • Previous experience supporting computer system validation efforts including authoring qualification deliverables.
  • Strong oral and written communication skills in English. Proficiency in MS Office suite.
  • Experience with electronic document management systems and testing applications such as HP ALM/HP Quality Center is a plus.


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