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Validation Specialist

QRC Group, LLC

Caguas, Caguas, Puerto Rico Full-time June 03, 2026
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Opportunity Description

Validation Specialist to support validation activities within a regulated Medical Devices manufacturing environment. The ideal candidate will have strong knowledge of the Validation Life Cycle and hands-on experience executing validation deliverables in compliance with FDA and global regulatory requirements.
Key Responsibilities:
  •  Execute and support validation protocols and reports including IQ, OQ, PQ for equipment, utilities, processes, and/or computer systems.
  • Ensure all validation activities comply with applicable regulations and site quality standards.
  • Lead and/or support the full Validation Life Cycle (planning, risk assessment, execution, and closure).
  • Develop and review validation documentation including Validation Plans, URS, FRS, RTM, protocols, and summary reports.
  • Participate in risk assessments (e...
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