QRC Group, LLC

Laboratory Equipment Validation Specialist

QRC Group, LLC  •  Manatí, PR (Onsite)  •  1 month ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

Job Description


The
Laboratory Equipment Validation Specialist

is responsible for the validation and lifecycle management of laboratory equipment used in a regulated pharmaceutical environment. This role ensures compliance with cGMP regulations through the planning, execution, and documentation of validation activities for analytical instruments, with a strong focus on
UPLC

systems and
densitometer

. The specialist will support laboratory operations by maintaining validated states and ensuring data integrity and regulatory compliance.


Key Responsibilities


  • Plan, execute, and document laboratory equipment validation activities.

  • Develop, review, and approve validation protocols, reports, risk assessments, and traceability matrices.

  • Perform validation of analytical laboratory instruments, including UPLC systems and densitometer, as well as other laboratory equipment as assigned.

  • Ensure compliance with cGMP.


Requirements


  • Bachelor’s degree in Science, or a related scientific discipline.

  • Minimum of three (3) years of relevant experience in a regulated laboratory in pharmaceutical environment.

  • Demonstrated hands‑on experience in the validation of
    UPLC systems and densitometer

    .

  • Strong knowledge of equipment qualification and validation requirements, data integrity principles, and applicable regulatory expectations.

  • Bilingual in English and Spanish (written and spoken).

  • Excellent technical writing, organizational, and communication skills.
  • 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
    Social Media