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IT Quality Analyst

Hawkins Point Partners is seeking to hire a Senior IT Quality Analyst to work as a member of their clients IT Quality & Regulatory Compliance team. The Sr. IT Quality Analyst will help to define, plan, and perform duties that support major system development life cycle activities—including qualification of IT infrastructure components, system validation and change control approval of IT systems documentation and change requests. In addition, this position is responsible for ensuring that other IT Controls procedural requirements are being met, including continuity management, risk management and incident/problem management.

DUTIES & RESPONSIBILITIES:

  • Approve system life cycle deliverables and activities to ensure that regulations, protocols, procedures, and methodologies are followed, and that appropriate and complete documentation is captured and reported to support infrastructure qualification and system validation activities.
  • Represent IT Quality & Regulatory Compliance on cross-functional teams in support of SDLC activities.
  • Consult on the authoring and conformance of qualification and validation related deliverables and activities in regard to corporate SOPs and current regulations.
  • Provide guidance, training, and support to IT personnel in their qualification and validation efforts, to ensure compliance.
  • Provide quality assurance oversight for system related issues (deviations, incidents, etc.)
  • Assist in the development of IT Controls templates (SDLC deliverables, System Assessments, etc.)
  • Advise technical personnel and management on regulatory compliance and interpretation and recommend appropriate corrective actions where needed.
  • Assist in the rollout of Quality Risk Management practices for IT

QUALIFICATIONS:

  • Thorough knowledge of GxP and ERES (21 CFR Part 11 and Annex 11) regulations and guidelines
  • Thorough knowledge of IT Controls methodologies, including GAMP5 and ITIL
  • Excellent communication skills, both verbal and written
  • Detailed knowledge of the general computerized system development life cycle in a regulated environment and software quality assurance
  • Knowledge of general software and database concepts
  • Experience with risk analysis and risk management practices and tools
  • Knowledge of infrastructure technology and platforms
  • The ability to work both independently and with teams at various levels in the organization
  • Excellent organizational skills and attention to detail and accuracy
  • Five or more years of experience in computerized system validation within a regulated environment
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