QA Specialist / Deviation Investigator

  • Contract

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

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.

Qualifications

  • 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.