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.