QA Specialist / Deviation Investigator

QRC Group, LLC • Carolina, PR

42d

About The Position

QA Specialist / Deviation Investigator to lead investigations of deviations, non conformances, and quality events within a regulated manufacturing environment.

Requirements

• Minimum 3–5 years of experience in deviation investigations, QA operations, or quality systems in regulated environments.
• Experience with GMP/GDP environments and documentation.
• Proficiency with CAPA methodologies and root‑cause‑analysis tools.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed