Quality Assurance Specialist II

4 weeks ago

Markham, Ontario, Canada Kuehne+Nagel Full time

About the Role

The Quality Assurance Specialist II will be responsible for supporting the ongoing maintenance and support of the Quality Management System at the local level within the assigned business unit(s). This role will execute branch Quality functions employing knowledge including but not limited to: corporate policies and guidelines, company work instructions, client SOP's and all the applicable Health Canada regulations associated with the functions performed at the assigned business unit(s).

Key Responsibilities

  • Support local Management within the Corporate Quality organization while maintaining site compliance to all Federal, Provincial and Local Quality requirements, as applicable to Distribution and/or Wholesaling activities.
  • Assist the flow of Operations including Inbound, Returns, and Facilitate product complaint/inquiry requests or investigations in accordance to client or Kuehne+Nagel requirements.
  • Monitor temperature conditions of the facilities and if applicable review inbound product temperature conditions.
  • Facilitate Preventative Maintenance activities and maintain a list of qualified vendors.
  • Maintain site documentation control and records retention for all local forms, working instructions, profiles, customer SOP's, and client specific documentation.
  • Assist with the creation of controlled documents (SOP's, WI's, and Forms, as assigned.
  • Review and sign off on QA records such as certificates of destruction, calibration records, sanitation and pest control.
  • Support operations in the maintenance of the site training program and applicable documentation.
  • Train and oversee Level I staff as assigned.
  • Facilitate development and implementation of change controls, WI's, and SOP's using working knowledge of GMP's and industry standards.
  • Supports Operations and/or completes, review and reporting of non conformance and planned deviation reports including root causes completeness and timely implementation of CAPAs.
  • Support and participate in client audits, internal facility audits and external audits on behalf of Kuehne+Nagel.
  • Provide data to support the monitoring, tracking and preparation of KPI's.
  • Support new client / product onboarding / setup preparation.

About You

  • Bachelor in Sciences (Pharmacy, Chemistry, Biology or a related discipline) is required.
  • 4+ years industry experience in Quality Assurance role.
  • 3+ years industry experience in Medical Device/Pharmaceutical distribution is preferred.
  • Working knowledge of Quality Management systems and standards (GMP, ISO 13485, ISO 9001).
  • Proficiency in French (written and verbal) an asset.

About Kuehne+Nagel

There has never been a better time to work in logistics. Bring your skills to an industry that offers stability and international career growth. We offer a great compensation and medical/dental benefits package, employee discounts, tuition reimbursement, excellent training programs, and a fun, and interesting global work environment.

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