Quality Assurance - Specialist
Charles River Laboratories International Inc (CRL)
Kaarst, DE, 41564
Job Summary
- Innerhalb unserer Abteilung Quality Assurance unterstützen Sie bei der Überwachung der Einhaltung regulatorischer Anforderungen im Bereich der Reagenzien Produktion und Keimidentifizierung
- Dabei überprüfen Sie die Dokumentation und übernehmen die Freigabe von Rohstoffen, Zwischen- und Endprodukten, sowie Analysenergebnisse
- Sie erkennen, bearbeiten und verfolgen Abweichungen von Arbeitsanweisungen, Herstellprotokollen und Spezifikationen
- Sie unterstützen bei der Erstellung von Änderungsanträgen und CAPAs und halten die Maßnahmen nach
- 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
- Sie unterstützen bei der Durchführung von internen Inspektionen zur Überwachung der Einhaltung von Vorschriften und internationalen Standards
- Teilnahme an Verbesserungs- und/oder Harmonisierungsprojekten qualitätsrelevanter Prozess
- Within our Quality Assurance department, you will support the monitoring of compliance with regulatory requirements in the area of reagent production and microbial identification
- You will check the documentation and approve raw materials, intermediate and end products as well as analysis results
- You will recognise, process and track deviations from work instructions, manufacturing protocols and specifications
- You support the creation of change requests and CAPAs and follow up on the measures
- Review SOPs, manufacturing records, reports and other quality-related and regulated records for accuracy, completeness and compliance with all applicable external and internal regulations and company policies
- Assist in conducting internal inspections to monitor compliance with regulations and international standards
- Participate in improvement and/or harmonisation projects of quality-related processes
Job Qualifications
- ein abgeschlossenes Studium der Naturwissenschaften oder des Qualitätsmanagements oder eine vergleichbare Qualifikation
- Kenntnisse über Qualitätssicherungs-Standards, wie z.B. ISO 9001, ISO 17025 und/oder GMP
- Teamfähigkeit und eine sorgfältige, strukturierte Arbeitsweise
- Durch gute Kommunikationsfähigkeit und analytische Fähigkeiten gelangen sie zu pragmatischen Lösungen
- Sehr gute deutsche und englische Sprachkenntnisse in Wort und Schrift
- Kenntnisse im Umgang mit den gängigen Microsoft Office Programmen (Excel/ PowerPoint/ Word)
- a degree in natural sciences or quality management or a comparable qualification
- Knowledge of quality assurance standards, such as ISO 9001, ISO 17025 and/or GMP
- Ability to work in a team and a careful, structured way of working
- Good communication and analytical skills to arrive at pragmatic solutions
- Very good written and spoken German and English language skills
- 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.
Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
Job posted: 2024-06-18
