QRC Group, LLC

QA Specialist / Deviation Investigator

QRC Group, LLC  •  Carolina, PR (Onsite)  •  6 days ago
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Job 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!

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.

QRC Group, LLC

About QRC Group, LLC

QRC group is a life science firm dedicated to provide services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Our services and solutions include:

Process and Laboratory Investigation

• Corrective and Preventive Action (CAPA)

• Change Control

• Training

• Document Management Control

• QA Laboratory

• Methodology Transfer and Validation

• Instrument Calibration

• Validation and Training in Chromatographic Data Acquisition System

• Cleaning Validation

• Automation Engineering

• Quality Systems

Industry
HR & Recruiting
Company Size
11-50 employees
Headquarters
Caguas, PR
Year Founded
2005
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