Quality Assurance Representative (QAR) – GLP Program Specialist

Canadian Nuclear Laboratories

Position Number25170

Are you ready for your next challenge? We are looking for a Quality Assurance Representative (QAR) – Good Laboratory Practice (GLP) Program Specialist! The core mission of the Quality Assurance organization is to enable the corporation to provide value-added products and services to its customers in full compliance with statutory and regulatory requirements to maintain CNL’s business and brand reputation. Through the provision of qualified quality professional resources, customer facing missions are supported with personnel to assist in the effective and efficient application of the quality program in evaluating actual performance to quality requirements through the application of independent verification. Provide CNL Quality Program support to the organization through guidance, oversight, and assurance that management system and quality-related requirements are met to ensure effective and efficient product and service delivery that is compliant with statutory and regulatory requirements through the provision of quality services dependent on the assigned functional team assignment. In a quality program specialist capacity provide single point of contact program expertise specifically in the implementation of “Good Laboratory Practice (GLP)” at CNL. This role, and associated responsibilities, are progressive in nature managed through continuous growth.

What will you be doing! 
•    Monitoring, verifying, supporting and advising on Quality program requirements and the implementation and effectiveness of procedures to ensure items, products and services required to be GLP compliant, are confirmed.
•    Providing awareness and guidance on the CNL Quality Program, relevant codes, standards and processes that support CNL’s assurance to customers.
•    Reviewing and verifying study plans, amendments, deviations, study reports, procedures and validation documentation are compliant with the Principles of GLP.
•    Verifying that methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies.
•    Verifying that approved study related documents in-use by personnel performing test facility activities are properly reviewed, revised/amended, re-approved and are fully implemented.
•    Reporting adverse conditions, observations, findings and nonconformities promptly to management (and defined GLP study stakeholders) and monitor corrective action(s).
•    Conducting independent assessments, audits, surveillance and inspections to ensure projects, facilities, resources, equipment and activities performed within the laboratories are adequate for the products and services they provide (including the conduct of GLP studies).
•    Reviewing and verify corrective actions as a result of audits, inspections and surveillances are complete and implemented.
•    Reviewing and verify nonconformities are dispositioned and include acceptable evidence to support that disposition.
•    Leading, participate in and/or verify that suppliers are assessed, evaluated and qualified to provide items, products and services for use in GLP studies.
•    Seeking preventive action supporting continual improvement through the use of the corrective action program.
•    Obtaining and maintain Quality Assurance Representative (QAR) qualifications and specifically those defined in training documents for the execution of this focused role.
•    Participating and assisting in the development of Quality Program documents including quality plans, procedures, job aids, training curriculum reports, etc.

What we are looking for:
•    Excellent working knowledge of management systems and support processes
•    Knowledge of CNL’s organizational structure, licensed facilities and operations are required.
•    Knowledge of OECD Principles of Good Laboratory Practice and relevant Health Canada Guidelines and the implementation and certification process.
•    Knowledge and experience in the application of standards such as but not limited to:
•    CSA N286, ISO 9001:2015, CSA N299 series, CSA N285, ASME Boiler & Pressure Vessel Code, CSA B51, ASME NQA-1 and 10CFR50 Appendix B,, ISO/IEC 17025 or ISO 10012, CSA N286.7, ISO 90003 or IEC 61513, CSA N288.4 and N288.5, ISO 14001.
•    Knowledge of compliance assurance, quality assurance, safety analysis, and CNL’s nuclear programs, such as security, environmental protection and radiological protection.
•    Understanding of the Canadian nuclear regulatory framework and ability to contribute to interpretations of regulations from regulatory agencies.
•    Proficiency in the use of a variety of software applications to compile data and create reports such as the use of Microsoft Office, Oracle and CNL’s Documents/Records management system.
•    Conducts their work with discretion and trust in the handling and safeguarding of confidential and sensitive information.
•    Commitment to quality work, adherence to standards and codes and CNL’s policies and procedures.
•    Auditing and/or assessment training and experience would be an asset.
•    Knowledgeable of the Company’s general policies and procedures, and the organizational structure of AECL in general.  Must have understanding of AECL’s business.  It would be an asset to have a working understanding of the work areas.
•    Superior interpersonal skills, efficient and effective communication (advanced written and oral) and organization skills are essential.
•    Capable of working independently and of making decisions in the absence of the Supervisor.
•    Demonstrates tact, diplomacy, trust, and discretion in handling and safeguarding sensitive and confidential information.  Able to handle conflict and manage towards a positive outcome.
•    Good judgment, initiative, strong drive, positive attitude and consistent, careful attention to detail are essential in this position to ensure accurate work and meet client/customer requirements, solve problems, obtain, and analyze data.
•    Demonstrated commitment to quality work and professional standards.
•    Must lead change and help others to accept and understand change, share their skills and proactively learn new skills.
•    The work for which they are responsible must be performed accurately and with attention to detail, under the pressure of stringent deadlines.
•    The position will require contact with the public and regulatory agencies, thus a need for tact and diplomacy.
•    Must be able to assimilate and resolve technical and regulatory issues.
•    Requires energy, flexibility and an ability to work in a team environment.
•    Identify conditions adverse to quality and report these to the appropriate level of line management, up to the Director of Quality as required to resolve quality-related issues.
•    Monitor performance against stated quality objectives and measures.
•    The Quality Assurance Representative must have initiative, a tactful and diplomatic manner, sound judgement and organizational abilities, excellent oral and written communication skills and be capable of working with minimum supervision.
•    Direct experience in a GLP governed work environment is preferable.
•    The ideal candidate will have at least 3 years of full-time experience in a laboratory environment with responsibility for Quality Assurance and Quality Control implementation.
•    At minimum, a Bachelors (Honour) in Engineering or Science from a university of recognized standing; or membership in an engineering or scientific professional organization authorized by statute to establish qualification for membership in that organization.
•    Security clearance eligibility required: Reliability Status with Site Access Security Clearance (SASC), which has a minimum requirement of 7 years of verifiable history in Canada, Australia, New Zealand, United States and/or the United Kingdom. CNL implements security screening in accordance with the Treasury Board of Canada Secretariat “Standard on Security Screening” and the “Policy on Government Security”.

Why CNL?
Does working with a team across Canada to advance nuclear science and technology for a clean and secure world speak to you? We’re reinventing ourselves to be the pace setters, so we can lead the charge in solving the problems that matter, like building the next generation of clean nuclear and hydrogen energy solutions, developing new and better-targeted cancer treatments, and continuing to lead the world in environmental remediation.

We offer a complete total rewards package: 
o paid time off (vacation, sick, floater & personal);
o benefits effective day one, that’s right no waiting period;
o tuition support
o and a pension!

CNL works with employees across our Canadian locations to enable a hybrid workforce where possible.  Our Hybrid employees work with their manager to establish expectations for when they will be on site vs when they are working from home.

About CNL: 
CNL is Canada’s premier nuclear science and technology organization and a world leader in developing nuclear technology for peaceful and innovative applications. Using our unique expertise, we are restoring and protecting the Environment, we are advancing clean energy technology, and our medical breakthroughs continue to improve the health of people around the world.

Our Priorities: 
• Clean energy for today and tomorrow.
• Restore and protect the Environment.
• Contribute to the health of Canadians.

CNL is committed to providing an atmosphere free from barriers that promotes equity, diversity and inclusion in achieving our mission. CNL welcomes and celebrates employees, stakeholders and partners of all racial, cultural, and ethnic identities.

CNL also supports a workplace environment and a corporate culture that is built on our Core Values: Respect, Teamwork, Accountability, Safety, Integrity and Excellence which encourage equitable employment practices and career prospects inclusive of accommodations for all employees.

CNL is committed to being an equal-opportunity employer. If you require accommodation measures during any phase of the hiring process, please indicate via our ATS when applying. All information received in relation to accommodation requests will be kept confidential.

The Chalk River Laboratories site is located on the unceded and unsurrendered territory of the Algonquin Anishinaabe people. As an organization, CNL recognizes and appreciates their historic connection to this place. CNL also recognizes the contributions that First Nations, Métis, Inuit and other Indigenous Peoples have made, both in shaping and strengthening this community in particular, and this province and country as a whole.