Sr QA/IT Infrastructure Qualifications Specialist

Location: New York Area

Job Description

We are seeking a Sr. Quality/IT Infrastructure Qualifications Consultant to work with our team onsite at our client site on a long term assignment. You will work on IT QA infrastructure qualifications and conduct periodic review activities and work with Quality/Validation staff to oversee infrastructure qualifications, as well as support and facilitate compliance/validation activities. 


Essential Duties and Responsibilities

  • Coordinate and manage hardware, software, network resources and services required for the existence, operation and management of an compliant enterprise IT environment 
  • Conduct periodic review and evaluate processes, SOPs, documentation;  corrective/remediation actions.
  • Assist Staff with the development of deliverables needed for IT infrastructure Qualifications.


Qualifications

  • College degree and 7 plus years of Quality, Validation and IT infrastructure qualifications related experience 
  • Significant experience conducting reviews of systems/software and equipment for compliance  
  • Proven experience with regulatory guidelines & insuring compliance (FDA/GAMP/Part 11)
  • Outstanding communication, analytic, and organizational skills with attention to details
  • Ability to effectively work independently in a deadline driven team environment
  • Demonstrated technical competence through serving as a Lead/Advisory resource