QRC Group, LLC

QA Specialist / Deviation Investigator

QRC Group, LLC  •  Carolina, PR (Onsite)  •  1 day ago
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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.


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.
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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