Job Description

It's More Than A Job
At Kuehne + Nagel, the Quality Assurance Specialist supports and maintains the Quality Management System (QMS) for local distribution and wholesaling operations. This role ensures compliance with Good Manufacturing Practices (cGMPs), corporate policies, client Standard Operating Procedures (SOPs), and Health Canada regulations covering narcotics, controlled drugs, and precursors.
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Join Kuehne + Nagel as a Quality Assurance Specialist and play a vital role in ensuring the safe and compliant distribution of healthcare products across Canada. In this position, you'll oversee the local Quality Management System, support day-to-day branch operations, and uphold the highest standards of quality and regulatory compliance. You'll be trusted as the Responsible Person in Charge (or Alternate) for transactions involving controlled substances and precursors, ensuring integrity and accountability. This is a unique opportunity to make a meaningful impact on patient safety while growing your career with a global leader in logistics and supply chain solutions.
How you create impact
The Quality Assurance Specialist 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: cGMP's, 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.).

• Facilitate and execute implementation and compliance activities as per cGMP's, corporate policies and procedures, client SOP's and applicable regulations across all business and functional units (Distribution and/or Wholesaling).
• Ensure that existing and future QA / GxP requirements are cascaded to and implemented at the site(s)
• Assist the flow of Operations including Inbound, Returns, Destruction, etc. where Quality support may be required.
• Release and/or quarantine product in accordance to client or KN instructions and regulatory requirements.
• Inspect finished products and oversee product sampling for testing and retention purposes per client or KN requirements.
• Issue Partner Notifications to clients and facilitate activities.
• Facilitate and/or Lead product complaint/inquiry requests, investigations and trending as per client or KN requirements.
• Monitor temperature conditions of the facilities if applicable review inbound product temperature conditions.
• Facilitate and oversee Preventative Maintenance activities and maintain list of qualified vendors.
• Maintain site documentation control and records retention for all local forms, WIs, SOP's, and client specific documentation.
• Review, sign off, and oversee QA records such as certificates of destruction, calibration records, sanitation, etc.
• Monitor training and follow up with Ops as required.
• Train QA Associate/Specialist/Intern position as assigned.
• Support Operations in the maintenance of the site training program and applicable documentation.

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.
What we would like you to bring

• Bachelor in Sciences (e.g. Pharmacy, Chemistry, Biology or a related discipline) is required
• 5+ years industry experience in Medical Device/Pharmaceutical industry in Quality Assurance
• 3+ Industry experience in Medical Device/Pharmaceutical distribution preferred
• Advanced knowledge and understanding of GMP's, GDP's, licensing, Federal and Provincial regulations and guidelines
• Proficiency in Quality Management systems and standards (i.e. GMP, ISO 13485, 14001, 90001, 180001)
• Experience with warehouse inventory management systems (WMS). SAP knowledge is considered an asset.

What's in it for you
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. Kuehne+Nagel is committed to Equal Employment Opportunity ("EEO") and to compliance with all federal, state, and local laws that prohibit workplace discrimination and unlawful retaliation. Kuehne+Nagel strictly prohibits all discrimination on the basis of race, ancestry, color, age, national origin, ethnicity, religious creed or belief, physical or mental disability, marital or familial status, legally protected medical condition, genetic information, military or veteran status, sex (including pregnancy, childbirth, breastfeeding, or related medical condition), gender (including gender identity and gender expression), sexual orientation, citizenship status, protected activity (such as opposition to or reporting of prohibited discrimination or harassment. Kuehne+Nagel will also make reasonable accommodations for disabled applicants and employees, including accommodations for pregnancy and childbirth, and for the sincerely held religious beliefs of applicants and employees depending upon individual circumstances unless such accommodation would create an undue hardship on Kuehne+Nagel #LI-onsite
Who we are
Logistics shapes everyday life - from the goods we consume to the healthcare we rely on. At Kuehne+Nagel, your work goes beyond logistics; it enables both ordinary and special moments in the lives of people around the world.
As a global leader with a strong heritage and a vision to move the world forward, we offer a safe, stable environment where your career can make a real difference. Whether we help deliver life-saving medicines, develop sustainable transportation solutions or support our local communities, your career will contribute to more than you can imagine.

Skills Required