For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Job Summary
1. Innerhalb unserer Abteilung Quality Assurance unterstützen Sie bei der Überwachung der Einhaltung regulatorischer Anforderungen im Bereich der Auftragstestungen und Reagenzien Produktion
2. Dabei überprüfen Sie die Durchführung und Dokumentation der Testungen im Labor und unterstützen die Freigabe von Rohstoffen, Zwischen- und Endprodukten
3. Sie erkennen, bearbeiten und verfolgen Abweichungen von Arbeitsanweisungen, Herstellprotokollen und Spezifikationen
4. Sie unterstützen bei der Erstellung von Änderungsanträgen und CAPAs und halten die Maßnahmen nach
5. Sie überprüfen SOPs, Herstellprotokolle, Berichte und andere qualitätsbezogenen und regulierten Aufzeichnungen auf Genauigkeit, Vollständigkeit und Übereinstimmung mit allen geltenden externen und internen Vorschriften und Unternehmensrichtlinien
6. Sie unterstützen bei der Durchführung von internen Inspektionen zur Überwachung der Einhaltung von Vorschriften und internationalen Standards
7. Teilnahme an Verbesserungs- und/oder Harmonisierungsprojekten qualitätsrelevanter Prozess
8. Within our Quality Assurance department, you will assist in monitoring compliance with regulatory requirements in the area of contract testing and reagent production.
9. You will review the performance and documentation of laboratory testing and support the release of raw materials, intermediate and end products.
10. You will identify, process, and track deviations from work instructions, manufacturing protocols, and specifications.
11. You will assist in the preparation of change requests and CAPAs and monitor the measures according to
12. You will review SOPs, manufacturing protocols, reports, and other quality-related and regulated records for accuracy, completeness, and compliance with all applicable external and internal regulations and company guidelines
13. You will assist in conducting internal inspections to monitor compliance with regulations and international standards
14. Participation in improvement and/or harmonization projects for quality-related processes
Job Qualifications
15. ein abgeschlossenes Studium der Naturwissenschaften oder des Qualitätsmanagements (B.Sc./B.A.). Eine gleichwertige Kombination aus Ausbildung und Erfahrung kann als zufriedenstellender Ersatz akzeptiert werden
16. Erfahrung im Umgang mit mikrobiologischen Proben und deren Morphologie
17. Kenntnisse über Qualitätssicherungs-Standards, wie z.B. ISO 9001, ISO 17025 und/oder GMP
18. Teamfähigkeit und eine sorgfältige, strukturierte Arbeitsweise
19. Durch gute Kommunikationsfähigkeit und analytische Fähigkeiten gelangen sie zu pragmatischen Lösungen
20. Sehr gute deutsche und englische Sprachkenntnisse in Wort und Schrift
21. Kenntnisse im Umgang mit den gängigen Microsoft Office Programmen (Excel/ PowerPoint/ Word)
22. a degree in natural sciences or quality management (B.Sc./ B.A.). An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
23. Experience in handling microbiological samples and their morphology
24. Knowledge of quality assurance standards, such as ISO 9001, ISO 17025 and/or GMP
25. Ability to work in a team and a careful, structured way of working
26. Good communication and analytical skills to arrive at pragmatic solutions
27. Very good written and spoken German and English language skills
28. Knowledge of the common Microsoft Office programmes (Excel/ PowerPoint/ Word)
About Microbial Solutions
Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.