Elena Kostadinova

Bis 2024, Quality Assurance Manager, Thermo Fisher Scientific
Berlin, Deutschland

Fähigkeiten und Kenntnisse

Management
Technology
Research and Development
Audit
Quality Management
ISO
Biology
Biotechnology
Biochemistry
People Management
QMS
ISO 13485
Quality Audits
ISO 9000
Quality Management Methods
International experience
Certification
Laboratory

Werdegang

Berufserfahrung von Elena Kostadinova

  • Bis heute 1 Jahr und 4 Monate, seit Apr. 2024

    Quality Assurance Manager

    midge medical GmbH

    • Ensured QA processes were followed to ensure maximum product quality • Developed and implemented a robust quality assurance process to ensure high-quality products

  • 2 Jahre und 2 Monate, Feb. 2022 - März 2024

    Quality Assurance Manager

    Thermo Fisher Scientific

    • managed the QA team of the branch & acted as Management Representative of the QMS • lead external audits and management reviews according to ISO 13485 • developed & tracked key performance indicators to measure the effectiveness of the quality assurance program • developed training materials & conduct seminars to ensure that all personnel understood & adhered to quality standards • collaborated with cross-functional teams to develop & implement QA processes that improved product reliability

  • 1 Jahr und 5 Monate, Sep. 2020 - Jan. 2022

    Quality Specialist

    midge medical GmbH

    • internal & external audits for ISO 13485 certification • EHS/OHS representative • responsible for the assessment and implementation of biotechnology-related standards required for the manufacturing of novel rapid diagnostic test for SARS-Cov2 • worked closely the biotechnology development team to define acceptance criteria & verification/validation plan tests following international guidelines and standards • defined risk mitigation measures and requirements for transfer to manufacture processes

  • 7 Monate, März 2020 - Sep. 2020

    Head of Quality & Regulatory affairs

    Leonyte Biosystems GmbH

    • QMB - maintenance of the internal QM system according to ISO 9001 • Lead internal and external audits & staff trainings related to ISO 9001 as well as with local authorities for maintenance of work laboratory certifications (e.g. for work with S2 Level human pathogens & for S2 Level GMO work) • Responsible for product/method validation studies design and planning as well as for the definition of quality objectives & processes (according to AOAC & ISO 16140 standards)

  • 2 Jahre und 2 Monate, Feb. 2018 - März 2020

    Senior Microbiologist and Innovation Manager Assay Development Lead

    Leonyte Biosystems GmbH

    • Established from scratch a Biosafety S2 Level Laboratory & certified it for work with human pathogens and GMO organisms • Technical day-to-day supervision & training of staff/Assay development team management • work closely with technical & business staff in developing ideas into grant proposals • conceptualize and execute high quality written applications, translating highly scientific content into terms that appeal to general scientific reviewers

  • 6 Monate, Sep. 2017 - Feb. 2018

    Grant&Subsidy Manager/Biology Team

    Leonyte Biosystems GmbH

    • responsible for the acquisition and management of grants and subsidies for R&D • involved in the development of a novel technology for real-time bacterial detection

  • 4 Jahre und 11 Monate, Okt. 2011 - Aug. 2016

    PhD Student

    Charite - Universitätsmedizin Berlin

    • Studied innate immune responses to bacterial pathogens in the lung • Trained and supervised biology/medical students (ZIBI Summer School) • Presented scientific reports at national and international conferences • Main techniques: primary cell isolation/culture · ECIS · ELISA · DNA/RNA isolation · RT PCR · qPCR · S. pneumoniae culture and infections · microscopy · microbiota analysis · in vivo murine infections

Ausbildung von Elena Kostadinova

  • 5 Jahre und 9 Monate, Okt. 2011 - Juni 2017

    Biology

    Freie Universität Berlin

    Infection biology, Microbiology, Immunology

  • 2 Jahre und 1 Monat, Sep. 2009 - Sep. 2011

    Biomolecular Sciences

    Vrije Universiteit Amsterdam

  • 2 Jahre und 11 Monate, Aug. 2006 - Juni 2009

    Biochemistry and Cell Biology

    Jacobs University Bremen

  • Freie Universität Berlin

Sprachen

  • Russisch

    Grundlagen

  • Bulgarian

    Muttersprache

  • Englisch

    Muttersprache

  • Deutsch

    Fließend

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