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Quality Assurance - Auditor 2

Req ID #:  37307
Location: 

Den Bosch, NB, NL, 5231DD

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 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 process and facility audits and reviews corresponding regulatory documentation to ensure compliance;
  • Assists in vendor and subcontractor audits;
  • Assists with sponsor and regulatory agency site audits;
  • Assists with harmonizing and improving quality processes;
  • Provides training for Charles River staff to leverage their knowledge and understanding of GLP compliance and other relevant quality systems.

 

The following are the minimum requirements related to the Quality Assurance Auditor  2 position:

 

  • A bachelor 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.

 

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 120 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 11,000 employees within 70 facilities in 18 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 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015.

 

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 ~70% of the drugs approved by the FDA in 2016.

 

For more information, please visit www.criver.com.


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