Job Details

  • Title: Application Testing Specialist
  • Code: RCI-34809-1
  • Location: Princeton New Jersey (NJ) 08543
  • Posted Date: 01/13/2021
  • Duration: 6 Months
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  Job Description

Position responsibilities include:

  • Working with the Hosting Services and Cloud Hosting Services teams (and Full-Stack Enterprise Service Providers) to assess new and existing infrastructure components/resources installations (server, DB and storage) and application tool installations and upgrades. Execute the qualification process as applicable, ensuring change requests are submitted per policy
  • Providing infrastructure qualification knowledge transfer to the Enterprise Service Providers for component level resources (server, database and storage qualification requirements) and application toolsets, and assistance with the creation or modification of related documentation
  • Performing ongoing quality review, monitoring and approval of related change tickets for the implementation and maintenance of such component level resources and applications
  • Ensure any deviations are documented, remediated and closed
  • Track and ensure qualified assets have an appropriate disposition
  • Ensure the qualification of infrastructure software or applications that interface/impact GxP applications
  • Ensure qualification documentation is efficiently managed and available for inspection
  • Providing Audit and Inspection request for infrastructure-related information and response knowledge transfer, assistance with the creation or modification of related documentation, and review/oversight of “live” requests/responses
  • Participate in status calls representing IT Quality Management
  • Serve as a qualification subject matter expert
  • Maintains close communication with stakeholders and team members to keep apprised of status and timelines
  • Reports status to management
  • Assist in the preparation of summary reports

Qualifications

  • Degree in computer science, information technology, life science or 5 years-experience in software quality assurance in the life sciences industry
  • Technically conversant in infrastructure concepts and techniques related to infrastructure toolsets, server rooms/data centers, servers, databases & storage
  • 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 qualification efforts including authoring, executing and reviewing qualification deliverables
  • Strong oral and written communication skills in English
  • Proficiency in MS Office suite
  • Experience with electronic document management systems (DocIT) and testing applications such as HP ALM/HP Quality Center is a plus
  • Open to creative, innovative, flexible and practical approaches to improving practices and solving problems