Helena Gómez Pozo
QA & RA Specialist at Overture Life- Claim this Profile
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Inglés Full professional proficiency
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Francés Elementary proficiency
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Español Native or bilingual proficiency
Topline Score
Bio
Credentials
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Technical Documentation for Medical Device Regulation (MDR) Training Course
BSIApr, 2022- Nov, 2024 -
Certificate in Advanced English
Cambridge Assessment EnglishAug, 2019- Nov, 2024 -
Diplôme D'Études En Langue Française-DELF B1
Ministère de l'Éducation nationale et de la JeunesseSep, 2015- Nov, 2024
Experience
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Overture Life
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United States
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Biotechnology Research
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1 - 100 Employee
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QA & RA Specialist
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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.
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Management and Development Intern (Medical Devices)
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Feb 2021 - Aug 2021
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Universidad de Alcalá
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Spain
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Education Management
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700 & Above Employee
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Intern researcher
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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"
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Education
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Universidad Carlos III de Madrid
Master, Gestión y Desarrollo de Tecnologías Biomédicas -
Universidad de Alcalá
Grado, Biología Sanitaria