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LMS - Computer System Validation Specialist - Remote

Columbia, MD · Information Technology
We are looking for a Computer System Validation specialist with experience validating Learning Management Systems. This is a remote, contract position.

Required Skills:

  • 3+ years of GxP System Validation/21CFR Part 11 within the Life Sciences field
  • Experience with validation of SaaS applications
  • Excellent experience with MS Office suite
  • Excellent oral and written communication skills
  • Solid understanding of project lifecycles and the comprehensive delivery process for GxP systems
  • Ability to work independently on CSV projects with minimal oversight
  • Experience with learning management systems (SuccessFactors, Saba, Sumtotal, etc.) a plus
  • Experience with application development and lifecycle management tools (QC, JIRA, etc.) a plus
Project Description:
  • Follow industry best practices for computer system validation.
  • Possess expertise on GxP practices, in order to guide those within the business that are less familiar.
  • Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on system validation, project validation status, and other relevant issues.
  • Assist in planning, implementing, and documenting user acceptance testing.
  • Obtain and respond to QA review.
  • Good understanding of Change Management process (preferably using ServiceNow)
  • Write validation documents such as:
  1. Requirements Specification
  2. Risk Assessment
  3. Validation Plan and Summary Report
  4. Test Plans (IQ, OQ, PQ)
  5. Test Summary Reports
  6. Data Migration Plan
  7. Traceability Matrix

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