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IT Quality Analyst

Hawkins Point Partners is seeking to hire an IT Analyst who will support our clients IT Quality & Regulatory Compliance operation team. This IT Analyst will also support all the major system development life cycle activities, including validation review and change control approval of IT systems. 

This job requires the IT Analyst to attend department and project meetings, administer essential tasks related to IT Training, and other ITQ processes. The IT Analyst must maintain a professional manner in representing ITQ and in working with its customers and associates. The IT Analyst should demonstrate initiative and self-direction while also knowing when to seek assistance. This person must also be able to routinely schedule and complete multiple tasks and be timeline driven. 


DUTIES & RESPONSIBILITIES: 

  • Administer ITQ processes, manage team meetings and action register 
  • Support ITQ team in the review of system life cycle deliverables and activities that ensure regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support validation activities. 
  • Assist in the development of IT Controls. 
  • Support administration of IT training records database 


QUALIFICATIONS

  • ​Seven or more years of experience in computerized system validation within a regulated environment 
  • Knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines 
  • Experience performing Risk Assessments, validating SAAS solutions and risk based validation approach
  • Detailed knowledge on Data Integrity Requirements 
  • Detailed knowledge of the IT system development life cycle and software quality assurance in a regulated environment 
  • Experience administering processes, scheduling and managing team meetings, and following up on action items 
  • Experience with MS Word, Excel, Outlook and other business software programs 
  • Experience with training records and document management systems 
  • The ability to work both independently and with teams at various levels in the organization
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