QA Specialist / Deviation Investigator

QRC Group, LLC · Villa Carolina, Carolina, Puerto Rico

Location
Villa Carolina
Job Type
Full-time
Posted
June 21, 2026

Job Description

Job Description
QA Specialist / Deviation Investigator to lead investigations of deviations, non conformances, and quality events within a regulated manufacturing environment.
Key Responsibilities:
  • Lead end‑to‑end investigations for deviations and quality events.
  • Collect and analyze data, conduct interviews, and review technical documentation.
  • Apply structured Root Cause Analysis tools (5 Whys, Fishbone, Fault Tree, etc.).
  • Develop and manage effective CAPAs addressing true root causes.
  • Prepare clear, compliant investigation reports aligned with GMP/GDP requirements.
  • Collaborate with Operations, QA, Engineering, and other cross‑functional teams.
  • Facilitate and lead problem‑solving and investigation meetings.

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