Specialist, Quality Assurance

cardinalhealth; Mississauga; Hybrid; CAD 58,000 - 70,000; Full time

Job summary

Cardinal Health Canada is seeking a Quality Assurance Specialist to join the Regulatory Affairs and Quality Assurance team. This hybrid role requires two days in our Mississauga Office. The Specialist will execute quality programs, create reports on metrics, and support SOP development while ensuring compliance with Health Canada and GMP standards.

Collaboration with cross-functional teams is essential. Anticipated salary range: CAD 58,200 – 69,750; Cardinal Health Canada values equity and

Qualifications

• Bachelor’s degree in Science or Health Canada degree equivalency required.
• 4+ years’ experience in related field preferred.
• Comprehensive knowledge of Health Canada Food and Drug Act, Canadian Medical Devices Regulations, Drug Regulations and GMP, Natural Health Product Regulations, Cosmetics and Consumer Regulations is an asset.

Responsibilities

• Assist in the implementation and execution of the Cardinal Health Quality System for Canadian facilities.
• Participate in site quality audits (internal and external).
• Assist with development of procedures and work instructions for quality programs.
• Execute established quality policies and procedures; assist in quality training programs.
• Maintain quality-related metrics for assigned country/region and provide guidance to operations on quality matters.
• Coordinate NC/CAPA investigations and resolutions for site events; support inspections, testing and release activities.
• Work with cross-functional teams to optimize quality programs and issue resolution.

Skills

Problem solving

Analytical

Communication skills

Education

Bachelor’s degree in Science or Health Canada degree equivalency

Job description

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 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 and reports to the Supervisor of Quality Management for Cardinal Health.

Your Contributions to the Organization will be to

• Assists in the implementation and execution of the Cardinal Health Quality System for one or more Canadian distribution facilities, as necessary
• Participates in site quality audits, (internal and external) as necessary
• Assist with the development of procedures and work instructions for quality programs
• Executes on established quality policies and procedures Responsible for assisting in conducting quality-related training programs, as needed
• Executes on established quality policies and procedures
• Maintains quality-related metrics for assigned country and/or region
• Provides ongoing guidance to operations personnel regarding quality matters
• Experience with the FDA and Health Canada regulations is desirable
• Experience with local/Regional quality regulations, as necessary
• Executes on Inspections, Testing and Release activities in Canada for National Brand and Cardinal Brand Canada Suppliers, as necessary
• Execute on rework/relabeling activities as per protocols Coordinate NC/CAPA investigations and resolutions for events occurring at the sites
• Works with cross-functional teams (Operations, RA, Finance, Customer Care, Supply Chain, Transportation. Commercial, etc.) to optimize quality programs and manage issue resolution
• Maintains quality-related metrics for assigned sites
• Coordinate NC/CAPA investigations and resolutions for events occurring at the sites

This Job might be for you if have:

• Bachelor’s degree in Science or Health Canada degree equivalency required
• 4+ years’ experience in related field, 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: $58,200 - $69,750

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.

Cardinal Health Canada is proud to be recognized as a Great Place to Work in Canada. As a key partner in the Canadian healthcare sector, we strive every day to create a culture of inclusion and collaboration, where team members can be themselves, grow in their careers, and take pride in serving our partner clients.

#LI-Hybrid

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 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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