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Quality Assurance Specialist II
4 months ago
Contract Logistics team. Your Role The Quality Assurance Specialist II will assume responsibility for the ongoing support and maintenance of the Quality
Management System at the local level within the assigned business unit(s), where Distribution and/or Wholesaling is applicable. 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) (e.g. narcotic control, controlled drugs and substances, precursors, etc.). You will report to Contract Logistics Quality Manager Your 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,
- 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, etc.) 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
If you require an accommodation for the recruitment /interview process (including alternate formats of materials, or accessible meeting rooms or other accommodation), please let us know and we will work with you to meet your needs.
Your Skills and Experiences- Bachelor in Sciences (e.g. 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 (i.e.: GMP, ISO 13485, ISO 9001)
- Proficiency in French (written and verbal) an asset
