Helena Gómez Pozo

QA & RA Specialist at Overture Life
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Contact Information
us****@****om
(386) 825-5501
Languages
  • Inglés Full professional proficiency
  • Francés Elementary proficiency
  • Español Native or bilingual proficiency

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Credentials

  • Technical Documentation for Medical Device Regulation (MDR) Training Course
    BSI
    Apr, 2022
    - Nov, 2024
  • Certificate in Advanced English
    Cambridge Assessment English
    Aug, 2019
    - Nov, 2024
  • Diplôme D'Études En Langue Française-DELF B1
    Ministère de l'Éducation nationale et de la Jeunesse
    Sep, 2015
    - Nov, 2024

Experience

    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • QA & RA Specialist
      • Sep 2021 - Present

      - Ensure compliance with quality and industry regulatory requirements- Requirements and component traceability- Follow-up risk management activities- Monitor testing and inspection of materials and products to ensure product quality.- Collect and compile statistical quality data. Analyze data to identify areas for improvement in the quality system.- Prepare reports to communicate outcomes of quality activities. Preparation of technical reports with the compilation of the results of the different tests.- Lab Manager, Lab Quality Assurance (GLP).- Preparation of audits and follow-up of the resulting actions.

    • Management and Development Intern (Medical Devices)
      • Feb 2021 - Aug 2021

    • Spain
    • Education Management
    • 700 & Above Employee
    • Intern researcher
      • Feb 2020 - Jun 2020

      - External practices- End-of degree project: "Study of urine metabolome by gas chromatography coupled to mass spectrometry and its application in the diagnostic analysis of prostate cancer" - External practices- End-of degree project: "Study of urine metabolome by gas chromatography coupled to mass spectrometry and its application in the diagnostic analysis of prostate cancer"

Education

  • Universidad Carlos III de Madrid
    Master, Gestión y Desarrollo de Tecnologías Biomédicas
    2020 - 2021
  • Universidad de Alcalá
    Grado, Biología Sanitaria
    2016 - 2020

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