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(Senior-) Laboratory Quality Specialist

vor 3 Monaten


Sankt Wendel, Deutschland Fresenius Medical Care Vollzeit

Ihre Aufgabe

Durchführung von Analysen mittels Gaschromatographie (GC), Hochleistungsflüssigkeitschromatographie (HPLC), sowie gekoppelter Massenspektrometrie (GC-MS, LC-MS, LC-QTOF), als auch Metallspurenanalytik (ICP-MS, ICP-OES) Durchführung von chemischen Analysen unter Einhaltung der ISO/IEC 17025 Standards Entwicklung und Validierung neuer Testmethoden nach ICH Q2(R2), Q14 und ähnlicher Guidelines Qualifizierung/Überwachung und Wartung der Laborgeräte Sicherstellung der Genauigkeit und Zuverlässigkeit der Testergebnisse Dokumentation und Berichterstattung gemäß den Qualitätsmanagement-Systemen Erstellen und Reviewen von SOPs im Verantwortungsbereich Aktive Beteiligung an Schulungen und Weiterbildungen

Ihr Profil

Abgeschlossenes Hochschulstudium in Chemie, Analytik oder einem verwandten Fachbereich ( Biologie, Biotechnologie) Mindestens dreijährige Erfahrung im GMP-Bereich erwünscht Tiefe Kenntnisse in der instrumentellen Analytik mittels GC, HPLC, Massenspektrometrie und ICP-MS Mehrjärhige Berufserfahrung in einem ISO/IEC 17025 akkreditierten Labor sowie im Bereich der Qualifizierung und Verwaltung von Prüfmitteln Mehrjährige Erfahrung im Bereich der Spurenanalytik, sowie des Themengebiets der Extractables/Leachables Überdurchschnittlich-strukturierte Arbeitsweise Starke analytische Fähigkeiten und Problemlösungskompetenz Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift Erfahrung im Umgang mit LIMS wünschenswert Career with a purposeWe offer an opportunity to create and deliver treatments that save and change lives for the better. We’ll support your ongoing development. And you’ll be part of a dedicated team of people who inspire each other to create the best possible healthcare outcomes each and every day. Inclusion and diversityJoining Fresenius Medical Care means becoming part of a team that values diversity. We embrace the wealth of different backgrounds, cultures, experiences and opinions that make up our workforce and strive to create an inclusive atmosphere in which all our employees feel valued. StabilityDeveloping innovative products and continuously improving our renal therapies made us the clear market leader in the production of hemodialysis machines, with sustainable, profitable growth . This position provides our 125000 employees with the stability and security they need to help improve the lives of our patients. Learning and developmentWe offer participation in programs at world-class business schools, leadership development, regular training for our nurses, health care professionals and manufacturing staff and digital access to high-quality educational content for all employees worldwide 24/7. Local benefitsOur employees enjoy both local and global opportunities for growth and personal fulfilment. We offer local benefits designed to suit the requirements of the respective country and place of work to create ideal conditions everywhere. Work-life balanceWe want to empower people to deliver better care. Therefore, we promote a better work-life balance through flexible working hours, part-time models, the possibility to work from home, and more.