For 75 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 1, for our Quality Assurance Department located in Reno, Nevada.
The position is responsible for performing audits of basic records and reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures. This individual will review protocols for compliance with all pertinent government and international GLP regulations for studies conducted at the Test Facility that are basic and routine in study design. The Quality Assurance Auditor will also prepare and review Quality Assurance files prior to Sponsor site visits; ensure that QA audit files are archived.

JOB QUALIFICATIONS

The following are minimum requirements related to the Quality Assurance Auditor 1 position.

• Bachelor’s degree (B.A./B.S.) required.
• 1 -2 years of experience preferred in science related field.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

• Assure Charles River’s compliance with applicable federal, state, and local regulations as well as corporate policies to avoid any business interruptions. Communicate all identified compliance and quality risks to supervisor.
• Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures.
• Review SOPs, protocols/batch records, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable regulations, international standards, and corporate policies and procedures.
• Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management.
• Participate in the preparation and review of study/batch record and QA files in preparation for sponsor/client site visits; assure that QA audit files are retained. May participate in the hosting of client site visits and support regulatory inspections.
• Participate in the development of corrective and preventative actions to respond to client visit and regulatory inspection findings.
• Identify, document, and report deviations from regulations, protocols/batch records, SOPs, and specifications.
• Review protocols and batch records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures.
• Independently perform inspections and audits to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations and international standards.
• Participate in inspections and audits of subcontractors, vendors, and suppliers of products and services.