Validation Specialist

Validation, IT, Security, Analyst, Business Analyst, FDA
Contract W2
Work from home not available Travel not required

Job Description

Classification: Contract
Contract Length: 12-months
Job ID: 12632953

At CereCore, our heart for healthcare is interconnected with our knowledge of technical solutions, creating a vital link that ultimately drives the delivery of high-quality care. CereCore is a wholly-owned subsidiary of Hospital Corporation of America (HCA) Healthcare.

CereCore is seeking a Senior Validation Specialist to join our team in Nashville, TN. This individual will work on-site at one of the nation's leading providers of healthcare services, HCA Healthcare.

  • Participate on computerized system validation and implementation project teams.
  • Author computer system validation documentation ensuring compliance with applicable regulations.
  • Participates on project teams (i.e., business, research applications, developers, IT Infrastructure and Security) throughout the installation, configuration, testing, and implementation process.
  • Works with development teams in translating functional requirements into clearly specified product features.
  • Works with other Information Technology teams for potential integration/functionality with existing applications.
  • Ensures continued regulatory compliance during software implementation projects and structured development life cycle practices and methodologies.
  • Authors validation deliverables including but not limited to risk/impact assessments, validation and qualification plans, design specifications, requirements traceability, and validation summary reports.
  • Works with Product Analyst/Business Analyst in the development of detailed requirements for each new validated system
  • Develops test strategies and defines test data (i.e. design the approach for testing each requirement).
  • Authors validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ).
  • Coordinates and oversee execution of validation and verification testing protocols/scripts for software under development and/or commercial off the shelf software products including identification and resolution of non-conformance/deviations.
  • Evaluates changes to the validated state of systems and determines validation requirements for applications through change control procedures and participate in the planning and implementation of changes; ensures completion of validation documentation before changes are implemented.
  • Tracks and manages change control activities for multiple concurrent projects.
Position Requirements:
  • 5+ years of information system validation, testing, or implementation experience
  • Must have a working knowledge of FDA regulations in clinical research
  • Knowledge of FDA GCP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines
  • Knowledge of EU regulations, e.g., Annex 11 is preferred
  • Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, and ICH is preferred
  • Familiar with Agile Methodology preferred
  • Leads in communicating requirements to development, testing, education and training teams

CereCore was formed in 2001 as a shared service business within a large hospital operator. We focus solely on helping healthcare organizations align business and IT strategies to improve processes and patient care.

Connect with us on LinkedIn, Twitter, and Facebook.

Dice Id : 10368247
Position Id : 12632953
Originally Posted : 2 months ago
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