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.

Responsibilities:
  • 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.

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