Quality Assurance Specialist

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 Assurance Specialist, Research Model Services (RMS) for our Quality Assurance Department located in Saint Constant, Canada.

The Quality Assurance Specialist is responsible for independently performing audits of a broad range of records and reports and inspections of a variety of processes to assure compliance with applicable regulatory requirements, international standards, and company policies and procedures.

**Job Qualifications**:

- Assures 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.
- Performs 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.
- Reviews SOPs, protocols/batch records, reports, and other quality and regulated records involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
- Generates written and signed reports of all audits and inspections as required in accordance with QA SOPs. Review audit reports as assigned.
- Coordinates the preparation and review of data and QA files in preparation for client site visits; assure chain of custody of all records
- Hosts client site visits and support external inspections.
- Coordinates in the development of corrective action to respond to client inspections.
- Identifies, documents, and reports deviations from regulations, equipment protocols, SOPs, and company policies.
- Provides recommendations to Regulatory Affairs and Compliance management for improvements in auditing of Quality Systems based on knowledge and understanding of regulations and quality principles.
- Reviews data, records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures.
- Leads inspections and audits of subcontractors, vendors, and suppliers of products and services.
- Assists in scheduling and assigning QA audits, inspections and procedures as assigned by QA management.
- Serves as the RMS-NA Vendor Program Committee backup representative for the Global Vendor Management Program.
- Works closely with Animal Welfare Specialists on issues, reviews and regulations.

**Job Requirements**:

- Bachelor’s degrees (B.A./B.S.) in Life Science is an asset.
- ALAT certification is an asset.
- 2+ years of experience in a QA or Auditing role in a research environment or Animal Facility/Vivarium.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Bilingual in both French & English. Being able to communicate effectively both verbally and by written communications.
- Must have experience with comprehending regulations and guidance documents.
- Proficient in Microsoft Office Suite (e.g. Word, Excel, Outlook).
- Domestic and International travel required - up to 30%.

**About Research Models & Services**
Fundamental to basic research and discovery is the use of in vivo models to help identify disease targets and determine potential biological pathways that regulate the condition. As the world’s leader in the production and distribution of the highest quality research animal, with 1 out of 2 animal models produced for preclinical research globally, we understand the importance of this step. With seven decades of experience, our expertise is unmatched, allowing us to provide you with the perfect model, including disease-specific and preconditioned options, for basic research and beyond.