QA Specialist / Deviation Investigator
QRC Group, LLC • Villa Carolina, Puerto Rico
Role 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.