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Quality Assurance Specialist II
1 month ago
Kuehne+Nagel is seeking a Quality Assurance Specialist II to join our Contract Logistics team in Markham. As a key member of our team, you will be responsible for supporting the ongoing maintenance of our Quality Management System and ensuring compliance with all relevant regulations and standards.
Your Role- Support local management in maintaining site compliance with federal, provincial, and local quality requirements.
- Assist in the flow of operations, including inbound and returns, and facilitate product complaint/inquiry requests or investigations.
- Monitor temperature conditions and review inbound product temperature conditions, as applicable.
- 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 SOPs, and client-specific documentation.
- Assist with the creation of controlled documents, such as SOPs, WI's, and forms, as assigned.
- Review and sign off on QA records, including certificates of destruction, calibration records, sanitation, and pest control.
- Support operations in maintaining 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.
- Support operations and/or complete, review, and reporting of non-conformance and planned deviation reports, including root causes 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.
- Bachelor's degree in Sciences (Pharmacy, Chemistry, Biology, or a related discipline) is required.
- 4+ years of industry experience in a Quality Assurance role.
- 3+ years of 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) is an asset.
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.
