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Validation Software Facilitator

North Chicago, IL 60064

Post Date: 08/14/18 Job ID: 46319 Industry: Data Analyst

HireLevel powered by Extra Help is seeking a Validation Software Facilitator for our client located in N Chicago, IL

Job Title: Validation Software Facilitator

Job Category: Full-time, 5 Month Contract

Location: N Chicago, IL

Similar positions: IT, Project Manager, Quality Control, Systems Analyst

Job Responsibilities of the Validation Analyst:
  • Responsible for all software quality assurance activities: evaluating software lifecycles, deliverables for compliance with Operating procedures and FDA requirements and the CFR including 21 CFR Part 11.
  • Lead or participate in various reviews, risk analyses and other software quality assurance activities.
  • Support data integrity program.
  • Create validation documentation.

Job Requirements of the Validation Analyst:
  • Bachelors degree or 3-5 years in regulated software industry experience required.
  • Experience with 21 CFR part 11 regulations.
  • Familiar with IEEE, SEI, ISO and have experience in a regulated environment.
  • Advanced knowledge of requirements gathering, analysis techniques, software verification/validation techniques, and configuration management techniques or documentation standards preferred.

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