Quality Assurance Specialist 2

Quality Assurance Specialist 2 Req ID #:  63951 Location: 

St. Constant, Quebec, CA, J5A 2E7 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 aQuality AssuranceSpecialist 2, Research Model Services (RMS) for ourQuality Assurance Departmentlocated in Saint Constant, Canada.

The Quality Assurance Specialist 2is 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. ESSENTIAL DUTIES AND RESPONSIBILITIES 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 withAnimal Welfare Specialists on issues, reviews and regulations. Job Requirements Bachelor’s degrees (B.A./B.S.). 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). Detail oriented. Works independently. Domestic and International travel required - up to 30%.

PREFERRED QUALIFICATIONS: Bachelor's degree (B.A./B.S) preferably in Life Science. ALAT Certification.

Competencies Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.

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.

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 17,000 employees within 90 facilities in 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. And in 2019, revenue increased  to $2.62 billion.

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 ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity 

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet

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