Responsibilities

  • Perform data audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, Standard Operating Procedures (SOPs) and study plans and their amendments.
  • 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 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.
  • 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.
  • Assist in scheduling and tracking QA audits, inspections and procedures as requested.

Requirements

  • Bachelor’s degree (B.A./B.S.) or higher, preferably in a life science or related discipline.
  • Good verbal and written communication skills
  • High degree of self-motivation with effective organizational and time management skills
  • Spoken and written communication in English
  • Computer skills including Word, Excel

Nice-to-have

  • 1-2 years professional experience preferred
  • previous work experience with animals and/or laboratory preferred

Company info

Our company belongs to the American Charles River Laboratories globally present corporation. Employees of Charles River have been working for more than 70 years to help discover, develop and safely manufacture new drug therapies. When you join our team, you will have a significant impact on people's health and well-being around the world. Whether you come from life sciences, finance, IT, sales or other areas, your expertise will play an important role in our work. In return, we'll help you build a career that you can really commit to.

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