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- Aufgaben: Support compliance monitoring in reagent production and microbial identification.
- Arbeitgeber: Join Charles River, a leader in drug therapy development with a global impact.
- Mitarbeitervorteile: Build a passionate career with opportunities for growth and development.
- Warum dieser Job: Make a difference in health and well-being while working in a collaborative environment.
- Gewünschte Qualifikationen: Degree in natural sciences or quality management; strong communication skills required.
- Andere Informationen: Be part of a team that has supported 85% of FDA-approved drugs in 2019.
Das voraussichtliche Gehalt liegt zwischen 36000 - 60000 € pro Jahr.
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
- 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
- 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.
- 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 This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit
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Quality System Specialist Arbeitgeber: Charles River Labs
Kontaktperson:
Charles River Labs HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Quality System Specialist
✨Tip Number 1
Familiarize yourself with the specific quality assurance standards mentioned in the job description, such as ISO 9001 and GMP. This knowledge will not only help you understand the role better but also demonstrate your commitment to quality management during the interview.
✨Tip Number 2
Highlight any experience you have with compliance monitoring or internal inspections in your previous roles. Be ready to discuss specific examples of how you've ensured adherence to regulations and improved quality processes.
✨Tip Number 3
Since good communication skills are essential for this position, practice articulating your thoughts clearly and concisely. Consider preparing a few scenarios where you successfully communicated complex information to a team or stakeholders.
✨Tip Number 4
Research Charles River Laboratories and their Microbial Solutions business group. Understanding their products and services will allow you to tailor your responses during the interview and show that you're genuinely interested in contributing to their mission.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Quality System Specialist
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Quality System Specialist position. Understand the key responsibilities and qualifications required, such as knowledge of quality assurance standards like ISO 9001 and GMP.
Tailor Your CV: Customize your CV to highlight relevant experience in quality assurance, compliance monitoring, and any specific projects that align with the responsibilities mentioned in the job description. Emphasize your educational background in natural sciences or quality management.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for quality assurance and your ability to work in a structured manner. Mention your communication skills and how they will help you in collaborating with teams and conducting internal inspections.
Highlight Language Proficiency: Since very good written and spoken German and English skills are required, make sure to clearly state your language proficiency in your application. Provide examples of how you've used these skills in previous roles.
Wie du dich auf ein Vorstellungsgespräch bei Charles River Labs vorbereitest
✨Understand Quality Assurance Standards
Make sure you are well-versed in quality assurance standards such as ISO 9001, ISO 17025, and GMP. Be prepared to discuss how your knowledge of these standards can contribute to compliance and quality improvement in the role.
✨Showcase Your Analytical Skills
During the interview, highlight your analytical skills by providing examples of how you've approached problem-solving in past roles. Discuss specific instances where you identified deviations and implemented corrective actions.
✨Demonstrate Teamwork and Communication
Since the role requires collaboration, be ready to share experiences that showcase your ability to work effectively in a team. Emphasize your communication skills, especially in both German and English, as this will be crucial for the position.
✨Familiarize Yourself with Charles River's Mission
Research Charles River's mission and values, particularly their commitment to improving health and well-being globally. Be prepared to discuss how your personal values align with theirs and how you can contribute to their goals.
