Quality Assurance Specialist Job at Charles River Laboratories
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.
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