Infrastructure Qualification Analyst

January 26, 2018
Nassau Park, New Jersey
Job Type
Education Required
Degree in computer science, information technology, life science or 5 years experience in software quality assurance in the life sciences industry


Requisition No.: 22476-1

Status: Full Time

Project Duration: 6 months

Position Description:

The Infrastructure Qualification Analyst position will provide the quality oversight for the migration of infrastructure devices (e.g. servers, databases and storage devices) for a large data center migration project.

Position responsibilities include:
• Working with the Infrastructure Services (IS) team to review upcoming wave migration activities and ensuring change requests are submitted per company policy
• QA review and approval of infrastructure migration tickets
• Ensure any deviations are documented
• 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 weekly migration status calls representing IT Quality Management
• Serve as a qualification subject matter expert on the migration 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

Skills Required

• Technically conversant in concepts and techniques related to servers, databases and storage devices
• Working knowledge of GAMP5 concepts, 21 CFR Part 11 and ITIL
• Strong oral and written communication skills in English
• Proficiency in MS Office suite

Skills Preferred

• Experience with electronic document management systems and/or HP ALM/HP Quality Center is a plus
• Open to creative, innovative, flexible and practical approaches to improving practices and solving problems

Experience Required

• Must have change management experience, preferably ServiceNow change management experience.
• Previous experience supporting computer system validation efforts including authoring qualification deliverables
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