Sandra Born

Angestellt, Fachspezialistin Qualitätsmanagement - Product Expert, medical technology, agap2 Deutschland
Weilrod, Germany

Fähigkeiten und Kenntnisse

Compliance-Verständnis
ISO 13485
DIN EN ISO 9001
Dokumentenlenkung
Molekularbiologie
Metabolic Engineering
Proteinbiochemie
GC-FID
GMP
Biochemie
Changemanagement
MS Office
SOP
Proteinreinigung
Genexpression
CAPA
MS Office Tools
GMP Compliance
Data Integrity
Erfahrungen bei Forschungsprojekten
Durchhaltevermögen
Teamwork
Ehrgeiz
Analytisches Denken
Zuverlässigkeit
hohe Lern- und Leistungsbereitschaft
Skype
Selbstständigkeit
Kommunikationsfähigkeit
Verantwortungsbewusstsein
Technisches Verständnis
Freundlichkeit
Strukturierte Arbeitsweise
Schnelle Auffassungsgabe
Erstellung von Berichten
Erstellung von Plänen
Datenanalyse

Werdegang

Berufserfahrung von Sandra Born

  • Current 2 years and 10 months, since Aug 2023

    Fachspezialistin Qualitätsmanagement - Product Expert, medical technology

    agap2 Deutschland

    Product Expert, Medical Technology Company - Planning of engineering studies on production lines in close cooperation with production, QA and validation to minimize risks identified from risk analyses - Analysis and summary of data in reports

  • 8 months, Jan 2023 - Aug 2023

    Fachspezialistin Qualitätsmanagement

    agap2 Deutschland

    Parental leave

  • 10 months, Mar 2022 - Dec 2022

    Fachspezialistin Qualitätsmanagement - GMP Compliance Manager

    agap2 Deutschland

    GMP Compliance Manager, pharmaceutical company in the field of blood plasma processing - Lead the team in the preparation of change control requests including administration and follow-up - Conducting regular production tours to verify and ensure GMP compliant manufacturing (clean room class C and D) - Revision and creation of standard operating procedures (SOP) in the context of process optimizations - Interface between production and QA - Data Integrity (production facilities and equipment)

  • 1 year and 6 months, Sep 2020 - Feb 2022

    Junior Fachspezialistin Qualitätsmanagement - Employee QM, medical technology

    agap2 Deutschland

    Employee Quality Management, In-vitro Diagnostics Company - Management and further development of the analog document system according to ISO 13485 and ISO 9001 - review of SOPs for compliance with internal requirements and standards conformity - Support in monitoring and management of ongoing CAPAs/Changes - Organization and participation in CAPAs for the maintenance & further development of the QM system, monitoring and tracking of measures - Support for internal and external audits (back office)

  • 3 years and 6 months, Oct 2016 - Mar 2020

    Research Assistant

    Goethe-Universität Frankfurt

    Institute for Mol. Biosciences, group Prof. Dr. E. Boles - Production of advanced biofuels by the yeast: - Management of research projects (research, planning, implementation, evaluation) - Presentation/documentation of scientific results - Content coordination, conceptual design and supervision of student internships or final theses - Supervision/cooperation with MTLA - Equipment responsibility for the GC systems (Perkin Elmer GC Clarus400/680: Repair, maintenance, contact person, analysis)

  • 4 months, Apr 2016 - Jul 2016

    Student Assistant

    Goethe-Universität Frankfurt

    Mentoring of the practical course "Biology for medical students - microbiology, genetic"

  • 4 months, Apr 2015 - Jul 2015

    Student Assistant

    Goethe-Universität Frankfurt

    Mentoring of the practical course "Biology for medical students - microbiology, genetic"

  • 3 months, May 2013 - Jul 2013

    Student Assistant

    Goethe-Universität Frankfurt

    Checking the functionality of ABC transporters using ATPase assays (optimization of the assay), protein expression, protein purification

  • 2 months, Mar 2013 - Apr 2013

    Intern

    Goethe-Universität Frankfurt

    Production of cysteinless mutant of an ABC transporter - molecular biological methods: targeted mutagenesis, digestion, transformation, plasmid preparation - protein chemical methods: expression, protein purification methods - analytical methods: agarose gel electrophoresis, SDS-PAGE, Western blot

  • 8 months, Mar 2012 - Oct 2012

    Temp

    PENNY - REWE Group

    Collecting and putting away the goods

  • 2 months, Aug 2011 - Sep 2011

    Intern

    Sanofi-Aventis Deutschland GmbH

    Department: Nucleic Acid Therapeutics Platform activities: Learning the basics of cell culture, creation of a stable overexpresing cell line, activity testing of siRNA

  • 2 years and 6 months, Feb 2009 - Jul 2011

    Temp

    PENNY - REWE Group

    Collecting and putting away the goods

Ausbildung von Sandra Born

  • 2 years, Oct 2014 - Sep 2016

    Molecular Biotechnology

    Johann Wolfgang Goethe University Frankfurt

    Master thesis at the Inst. for Mol. Biowiss., AK Prof. Dr. E. Boles, "Modulation of cell size and intracellular pH-value in Saccharomyces cerevisiae for biotechnological applications" Major field of study: White biotechnology

  • 3 years, Oct 2011 - Sep 2014

    Biochemistry

    Johann Wolfgang Goethe University Frankfurt

    Bachelor thesis at the Institute of Biochemistry, AK Prof. Dr. E. Tampe, "Affinity determination at the ABC export complex TmrAB from the Gram-negative eubacterium Thermus thermophilus". Priorities: Biophysical chemistry, inorganic and organic chemistry, genetics and microbiology

  • 8 years and 1 month, Jul 2002 - Jul 2010

    Zweig: Gymnasium

    Altkönigschule Kronberg

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    B1-B2 (Gute Kenntnisse)

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