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Cardinal Health

Quality Assurance Specialist

Reposted Yesterday
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In-Office or Remote
2 Locations
Junior
In-Office or Remote
2 Locations
Junior
The Quality Assurance Specialist ensures compliance with regulatory standards by developing quality policies, executing programs, and creating reports on quality metrics. They respond to quality issues, support audits, and collaborate on regulatory submissions, while developing technical skills in quality assurance.
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Cardinal Health Canada, with over 1300 employees nationwide, is an essential link in the Canadian healthcare supply chain, providing over 70,000 products to healthcare facilities and medical professionals across the country.

Cardinal Health Canada is currently seeking a 20-month contract for a Quality Assurance Specialist to join the Regulatory Affairs and Quality Assurance team. This role is a hybrid work-model with two days in our Mississauga Office.

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
The Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (such as recalls and customer complaints) in order to minimize risks and drive supply chain integrity. With basic knowledge of quality assurance concepts, the Specialist creates reports on quality metrics and trends in support of resolutions to quality issues and the development of standard operating procedures. The Specialist frequently seeks guidance from more experienced Senior Specialists or Principal Specialists and assists on more complex projects to develop advanced knowledge and technical capabilities.

For more information on what it is like to work for us, please watch this video: Cardinal Health - Wings.

Your Contributions to the Organization will be to:  

  • Ensures the fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls. Submits reports for internal review prior to submission to regulatory bodies.

  • Executes internal programs to define Quality guidelines and track adherence to these guidelines. Provides guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements.

  • Responds to significant quality issues and based on the direction from the Manager, creates reports on relevant quality metrics and trends and gathers relevant information from internal stakeholders.

  • Supports of the Change Control Program, by assessing Quality Assurance implications and impacts of operational and product changes, with a focus on specialty area.

  • Gathers necessary information from products and operations stakeholders and generates reports on quality metrics to assist Senior Specialists and the Manager in responding to regulatory queries, regulatory audits, and corporate.

  • Supports the Manager, Quality Assurance in quality audits and inspections of distribution centers within the region. Records quality issues and provides draft reports and insights to the Manager, for delivery to the Operations stakeholders.

  • Partners with Senior or Principal Specialist on complex regulatory submissions, operational recommendations, product analyses, and other tasks in order to develop advanced knowledge of relevant regulations and internal processes.

This Job might be for you if have: 

  • 0-2 years of experience, preferred

  • Bachelor's degree in related field, or equivalent work experience, preferred

  • Comprehensive knowledge of the Health Canada Food and Drug Act, Canadian Medical Devices Regulations, Drug Regulations and GMP, Natural Health Product Regulations, Cosmetics and Consumer Regulations, as an asset

  • Highly organized, problem solving, analytical and focused

  • Proven communication skills (verbal, written and presentation skills)

What is expected of you and others at this level

  • Applies basic concepts, principles and technical capabilities to perform routine tasks

  • Works on projects of limited scope and complexity

  • Follows established procedures to resolve readily identifiable technical problems

  • Works under direct supervision and receives detailed instructions

  • Develops competence by performing structured work assignments

Anticipated salary range: $57,300 - $76,400

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Cardinal Health is committed to employment equity and encourages applications from women, visible minorities, Indigenous peoples and persons with disabilities.

Cardinal Health is committed to accommodating applicants with disabilities throughout the hiring process, in accordance with the Accessibility for Ontarians with Disabilities Act (AODA). Our Human Resources team is responsible for working with applicants requesting an accommodation at any stage of the hiring process.

#LI-Hybrid

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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Top Skills

Gmp
Quality Assurance
Quality Guidelines
Quality Metrics
Regulatory Affairs

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