Quality Assurance Auditor II

Req ID #:  92951
Location: 

S-Hertogenbosch, NL, 5231 DD

For 70 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

We are seeking a Quality Assurance Auditor II for our Safety Assesment site located Den Bosch.

 

Do you have several years of experience as a GLP QA Auditor or are you employed in an OECD GLP environment, e.g. in a laboratory as Senior Analyst / Biotechnician or Study Director? Do you also have a keen eye for quality? If that's the case, we have a vacancy - stipulated below - that is aligned with your profile:

 

Job Summary

Conducts quality assurance audits on challenging multi-phase non- clinical studies within an OECD GLP lab environment. Responsible for process and facility audits to ensure regulatory compliance. We are seeking a Quality Assurance Auditor II within a group of 18 QA staff for our Safety Assessment site Charles River location Den Bosch/Schaijk.

 

Job profile:
•    Performs audits of protocols, in-life critical phases; raw data and final reports to assure compliance with Good Laboratory Practice Regulations (GLP) and Standard Operating Procedures (SOP);
•    Delivers advise to Charles River staff (including management and study directors) on issues relating to GLP compliance;
•    Performs or leads process and facility audits and reviews corresponding regulatory documentation to ensure compliance;
•    Assists in vendor and subcontractor audits;
•    Assists or host sponsor and regulatory agency site audits;
•    Harmonizing and improving quality processes;
•    Provides training for Charles River QA and lab staff to leverage their knowledge and understanding of GLP compliance and other relevant quality systems.
•    Provide recommendations for improvements in auditing of quality systems based on extensive knowledge and understanding of regulations and quality principles.

 

The following are the minimum requirements related to the Quality Assurance Auditor II position:
•    A bachelor’s degree in a scientific discipline;
•    Experience with GLP or a comparable quality system;
•    2-4 years of auditing experience
•    Strong knowledge of Dutch and English;
•    Good communication and advisory skills;
•    Work as a team member;
•    Accurate and quality minded.
•    Quickly in learning software programs.

 

We offer:
•    A challenging and independent position in a dynamic environment;
•    The possibility to develop further in a global team;
•    Good primary and secondary working conditions;
•    An open company culture with an informal atmosphere.

About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.  Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

 

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 17,000 employees within 90 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 - M/F/Disabled/Vet

 

<span style="font-family:"Arial",sans-serif">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 <span style="font-family:"Arial",sans-serif">crrecruitment_US@crl.com<span style="font-family:"Arial",sans-serif">. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications<span style="font-family:"Arial",sans-serif">.

 

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