Quality Assurance Specialist

1 week ago

Mississauga, Ontario, Canada Cardinal Health Full time

Cardinal Health, with over 1300 employees in Canada, 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 is seeking a positive individual to join the Regulatory Affairs and Quality Assurance team as a Quality Assurance Specialist.

This role is primarily responsible for the management of product recalls. This role will also support the product holds process and support product inspections for compliance with specifications and standards.


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_:

  • Manage product recalls for Cardinal brand and distributed products from initiation to closure.
  • Responsible for pulling and summarizing product traceability information from information systems.
  • Preparation of recall customer communications and coordination of recall mailings.
  • Liaise with internal stakeholders to ensure a recall strategy is established and communicated.
  • Responsible for preparing and submitting Health Canada recall reports.
  • Coordination of document translation required for recalls.
  • Follow up recall queries.
  • Play a supporting role for hold initiation, follow up and closure.
  • Supports product inspections and rework of finished goods, components, incoming materials.
  • Completes applicable documents needed for the release of product to the field.
  • Facilitate return or destruction of drug products or recalled products.
  • Prepare and summarize data, metrics and reports as required by management.
  • Prepare update, maintain and adhere to applicable SOPs.
  • Supports the following quality processes as required: Corrective Action / Preventive Action (CAPA), nonconformance, quality training, management review, document control, change management and records management.

_ This Job might be for you if you have:_

  • Bachelor's degree in relevant science discipline, preferred.
  • 13 years' experience in related field, preferred.
  • Applied 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.
  • Highly organized, problem solving, analytical and focused;
  • Proven communication skills (verbal, written and presentation skills).
  • Bilingualism (French and English, spoken and written), preferred.

_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 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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