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.
- 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.
About Safety Assessment
- 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.
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.