Quality Assurance Specialist

Req ID #:  207998
Location: 

St. Constant, Quebec, CA, J5A 2E7

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.

 

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   

Job Summary

 

As a Quality Assurance Specialist for our Quality Assurance team located at the St-Constant site,you are 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.

 

 

In this role, responsibilities may include

 

  • 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.
  • Coordinates the preparation and review of data and QA files in preparation for client site visits; assure chain of custody of all records
  • Coordinates in the development of corrective action to respond to client inspections.
  • 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.

 

Key Elements

 


 We are looking for the following  qualifications for this role :
 

  • Bachelor's degree (B.A./B.S) preferably in life sciences
  • ALAT certification is an asset.
  • 2+ years experience in a QA or Audit role in a research or Animal Facility / Vivarium environment
  • French and English required for the position, English language is necessary to support our US locations in their QA audits. The supervisor is also located in the US, the successful candidate for this role will have a lot of communication in English.
  • Understanding of English is mandatory. Bilingualism in French and English is preferred.
  • Must have experience in understanding regulations and guidance documents.
  • Proficiency in Microsoft Office Suite (e.g. Word, Excel, Outlook).
  • Domestic and international travel required - up to 30%.

 

 

Role Specific Information

 

Location: St-Constant
Permanent position as of the hiring, full time 37.5hrs per week

 

 

Why Charles River?

 

  • Competitive hiring benefits. We pay up to 85% of premiums (medical and dental coverage).
  • Paid developmental training
  • Employee and family assistance program
  • 24/7 access to a physician and various health care professionals (telemedicine)
  • 3  weeks’ Vacation & 5  Personal day policy 
  • Numerous organized social activities

 

If you want to contribute to the well-being of our communities, not only across the country, but also around the world, join the team, IT'S YOUR MOMENT!

 

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 
 

About Corporate Functions
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.  

 

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
 
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.
 

Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.


If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
 
For more information, please visit www.criver.com.


Job Segment: Quality Assurance, Pharmaceutical, Laboratory, Biotech, Technology, Science, Research