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Quality Associate QESH (m/w/d)

in Leipzig

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Job Description Job Attributes+

  • Req. ID

    R3869

  • Organization

    Life Science

  • Job Category

    Quality

  • Job Type

    Full time

  • Job Location

    Bahnhofstrasse 86
    Leipzig, 04158
    Germany

Overview

Unser Europäisches Quality Team bei Brooks Life Sciences Services sucht Verstärkung. Bewerben Sie sich als:

EU Quality Associate QESH*

The EU Quality Associate QESH* will work closely together with the Laboratory team, Life Science Project Managers and other functions to maintain and implement policies and procedures which result in attaining quality goals.
*QESH: Quality, Environment, Safety & Health

Ihre neue Herausforderung:

Als EU Quality Associate QESH* arbeitet mit verschiedenen Abteilungen (Labor, Projektmanagement etc) zusammen, um das aktuelle SOP System zu pflegen und weiterzuentwickeln. Zeitgleich sollte das bereits an anderen Standorten genutzte elektronische Dokumentationssystem (eDMS) am Standort Leipzig eingeführt werden.
*QESH: Quality, Environment, Safety & Health

  • Unterstützung der Einführung des global genutzten eDMS Qualtrax

  • Zusammenarbeit mit QA-Mitarbeiteren an verschiedenen Standorten um das QMS zu harmonisieren

  • Assistenz bei Vorbereiten und Durchführen von internen Audits

  • Assistenz beim Vorbereiten, Durchführen und Nachbereiten von Kundenaudits

  • Unterstützung und Training der Mitarbeiter in Qualitäts-Fragen

  • Revision und Überprüfung von Dokumenten (Policies und SOPSs).

  • Überprüfen von Validierungsdokumenten (zB. Gerätequalifizierung) 

  • Pflege des Dokumentenarchivs (intern und extern)

  • Pflege der abteilungsinternen Dokumente, (QA Logs) sowie Übernahme von administrativen Tätigkeiten, einschließlich Erstellung und von Dokumenten

  • Arbeitssicherheit: Übernahme der Aufgaben des Sicherheitsbeauftragen, Ansprechpartner für die Fachkraft für Arbeitssicherheit, das Management und Mitarbeiter in Fragen der Arbeitssicherheit 

  • Weitere Tätigkeiten nach Anfallen, delegiert vom EU Quality Manager

  • Gelegentliche Reisetätigkeit (auch international)


Außerdem:

  • Gemäß bereits bestehender QMS und/oder GLP -Prozesses arbeiten, und diese, in Zusammenarbeit mit QA Kollegen, am Standort Leipzig einführen bzw. durchsetzten.

  • Zusammenarbeit mit verschiedenen Abteilungen um Compliance und/ oder Prozesse der Qualitätskontrolle zu entwickeln.

  • Sicherstellung, dass Abweichungen identifiziert, untersucht und angemessen geklärt werden. Falls nötig, sollte gemeinsam mit dem Kunden nach einer Lösung gesucht werden. Förderung von kontinuierlicher Verbesserungsprozessen und  im Unternehmen.

  • Ansprechpartner und Zusammenarbeit für/mit BLS Mitarbeiter um gemeinsame Ziele zu erreichen und eine harmonisches/kontrolliertes Arbeitsumfeld sicherzustellen

Ihr Profil:

  • Ausbildung/ Abschluss  im Bereich Life Scienes (Technischer Assistant , Bachelor/Diplom/Master)

  • Grundlegende Erfahrung der Arbeit in einem kontrollierten Umfeld

  • Praktische Erfahrung im Labor

  • Hohes Maß an Eigeninitiative und Fähigkeit zum unabhängigen Arbeiten.

  • Starke analytische Fähigkeiten und die Fähigkeit, kreativ zu denken.

  • Starke Kommunikations- und zwischenmenschliche Fähigkeiten, sowohl schriftlich als auch mündlich.

  • Effizientes Handeln in einer Umgebung mit dynamischen Zeitplänen und Prioritäten.

  • Versiert im Umgang mit Microsoft Office-Produkten wie Outlook, Word und PowerPoint.

Von Vorteil:

  • Erfahrung im Arbeitsumfeld von Brooks Life Sciences

  • Erfahrung im Bereich Qualitätsmanagement, SOP-Erstellung, Richtlinien

  • Erfahrung mit FDA/ ISO 9001 und/oder Kundenaudits

  • Kenntnisse der GLP Regularien

  • Praktische Erfahrung im Bereich Arbeitssicherheit/biologische Sicherheit

Über uns

GENEWIZ ist ein international tätiges Life-Science Unternehmen mit Kunden aus Industrie, Pharma und Akademie. Zu unseren Dienstleistungen gehören DNA-Sequenzierung, Next-Generation Sequenzierung, Gensynthese, Molekularbiologie sowie bioinforma-tische und GLP-konforme Services. Das Europäische Headquarter von GENEWIZ, mit unseren kürzlich eröffneten und hochmodernen Sequenzier-Laboren, befindet sich im Norden von Leipzig. Gemeinsam mit unserem Mutterkonzern Brooks Automation, einem weltweit führenden Anbieter von Automatisierungs- und Vakuumlösungen sowie Halbleiterfertigung und Life Sciences, stehen wir für eine kundenorientierte Kultur und fördern bei unseren Mitarbeitern innovatives und zukunftsorientiertes Denken.

Kontakt

  • GENEWIZ Germany GmbH; Bahnhofstraße 86; 04158 Leipzig

  • eMail: Sebastian.Schaedler@brooks.com

Weitere Informationen zu unserem Unternehmen finden Sie unter https://www.brookslifesciences.com.
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JOB LOCATION

Genewiz

Bahnhofstrasse 86
Leipzig,   04158

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