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Quality Assurance Specialist


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 Specialist for our Insourcing Solutions site in Bethesda, MD.

 

Review Statement of Work (SOP) for compliance with all applicable governmental and site-specific regulations. Schedule and conduct critical phase inspections of laboratory studies and facility inspections for compliance with internal standard operating procedures, study protocols. Review quality assurance records, reports and training records for accuracy and compliance with all applicable regulations and client guidelines. Compose and submit written records of all inspections within the required timeframe. Audit compliance with Company policies, procedures and management guidelines. Provide recommendations for policy and procedure updates as appropriate.

 

Enter, update and edit Quality Assurance files and records and training resources. Coordinate with high-level Tech Staff, Task Leaders, client representatives and corporate management to facilitate and optimize quality compliance practices in overall study conduct, data collection and reporting. Develop and present quality assurance training for Division staff. Review and evaluate effectiveness of training presented. Comply with health standards of supporting contracts and company health programs. Ensure optimal performance of the quality assurance function by recommending and implementing techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities and maintain superior practices.

 

Individuals must possess the following:

  • Education: Bachelor’s degree, preferably in a life science or equivalent.
  • Experience: Two (2) to four (4) years in Quality Assurance or Facility Operations function.
  • An equivalent combination of education and experience may be accepted as satisfactory substitute for the specific education and experience listed above.
  • Certification/Licensure: AALAS certification at the Laboratory Animal Technologist (LATG) level

 

About Insourcing Solutions
Charles River Insourcing Solutions℠ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutions℠ provides you with the ability to maintain control of your facility and expertise while leveraging available space.

 

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 13,000 employees within 80 facilities in 23 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.

 

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 80% of the drugs approved by the FDA in 2017.

 

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

 

Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet