Quality Systems Auditor

Req ID #:  136271
Location: 

Ashland, OH, US, 44805

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 Systems Auditor for our Safety Assessment group site located in Ashland Ohio.


Responsible for performing non-study based inspection of vendors and internal facility programs and providing regulatory support for training, client visits, and other quality initiatives.


Responsibilities:

  • Perform and/or oversee internal facility inspections at planned intervals to evaluate effective control and maintenance of site quality systems.
  • Provide support with Quality by Design Optimization projects
  • Perform and/or oversee vendor audits at planned intervals to evaluate effective control and maintenance of site quality systems.
  • Develop, manage and provide training to QA auditors.
  • Oversee and/or perform site GLP training program.
  • Provide QA support in the validation of computer programs.
  • Perform and/or oversee the generation of quality summary reports to management
  • Manage and/or oversee all aspects of internal client visits and related reporting and metric summary
  • Provide support with Quality Risk Management Initiatives
  • Ensure Data Integrity standards are communicated and effectively monitored
  • Support Charles River quality initiatives.
  • Perform all other related duties as assigned.

 

Qualifications:

  • Bachelor's degree (B.S./B.A.) preferably in a life science, or equivalent.
  • Minimum of 3 to 5 years in a Quality Assurance role.
  • Experience with word processing and spreadsheet programs such as Word, Access and Excel.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

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.

 

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 crrecruitment_US@crl.com. 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 www.criver.com.


Nearest Major Market: Cleveland
Nearest Secondary Market: Mansfield

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