Sr Quality Engineer, Computerized Systems Quality & Management at Gardner Resources Consulting, LLC in Boston, Massachusetts

Posted in Other about 19 hours ago.

Type: full-time





Job Description:

Sr Quality Engineer, Computerized Systems

Must Have:
  • 7 years Computer Systems
  • Validation
  • Compliance - quality oversight
  • GMP
  • Proficient with Computerized systems on Enterprise Level, Lab Systems, and Manufacturing Systems and provide Quality oversight on the related system projects
  • Bachelor's degree in IT or Computer Science
  • 5+ years of proven experience in computerized systems, Enterprise Level and Lab systems validation/quality capacity
  • Familiarization with ITIL/GAMP5 Validation Lifecycle
  • 21 CFR, EU regulations
  • Take Quality ownership, participate in cross functional team discussions, provide quality guidance/decisions for the projects that includes New implementation, Enhancements, Quarterly releases, etc.
  • Participate and Drive System Assessments, review and approve the project deliverables including plan, test scripts, execution and its outcome, reports, traceability

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