Quality Assurance Auditor

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.

Perform audits of basic records and reports and inspections of routine processes to assure compliance with applicable GLP regulatory requirements.

• Assure Charles River’s compliance with applicable GLP . 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, SOPs, and protocols.
• Review SOPs, protocols, reports, and other quality and regulated records for accuracy, completeness, and compliance with all applicable GLP regulations.
• Maintain written and signed records of all audits and inspections as required and sign records documenting the performance of audits and inspections and reporting to management.
• Identify deviations from GLP regulations, protocols and SOPs.
• Independently perform inspections to monitor processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with GLP regulations.
• Assist in scheduling and tracking QA audits, inspections and procedures as requested.
• Perform all other related duties as assigned.

• Education:
  
  Bachelor’s degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.
• Experience:
  
  1-2 years experience in QA role
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure:
  None.
• Other:
  Knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing.

• Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
• Must regularly communicate with employees/customers; must be able to exchange accurate information.
• Must occasionally move about inside the office to access file cabinets, office machinery, etc.
• May occasionally be required to wear protective clothing and equipment.

• General office working conditions and/or laboratory/manufacturing areas.
• The noise level in the work environment ranges from low to moderate.
• May occasionally be required to work in tight or confined spaces.
• May occasionally be exposed to high temperatures and humidity.

Four-year degree required

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…