JVT Advisors

I.T. Quality Analyst

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Location: Somerville, Massachusetts
Employment Type: Contract

Job Description

IT Quality Analyst: Location Somerville, MA

Contract length: 12 Months

Qualifications

  • Bachelor's/Master's Degree 
  • 7+ years IT Quality / Validation experience in computerized 
    system validation within a regulated environment preferably R & D application. 
  • Thorough knowledge of GxP and ERES regulations and guidelines 
  • Experience and knowledge of the IT system development life cycle,
    software quality assurance in a regulated environment, and risk analysis and management practices and tools.
  • Thorough knowledge of IT Controls methodologies, including GAMPS and ITIL 
  • Excellent communication skills


Responsibilities

  • Approve system life cycle deliverables (SDL) and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and appropriate and complete documentation is captured and reported to support validation activities. 
  • Consult on the authoring and conformance of validation-related deliverables and activities in regard to corporate SOPs and current regulations. 
  • Provide guidance, training and support to IT
  •  Provide quality assurance oversight for system related issues. 
  • Advise on regulatory compliance and interpretation and corrective actions where needed. 


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Justin McKay

Principal Life Sciences Recruiter

With extensive industry experience and specializing in our Life Sciences & Technologies practice area, Justin enjoys helping candidates find their next perfect employment opportunity.

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