Quality Assurance Specialist Ii

We are looking for a Quality Assurance Specialist II for our Contract Logistics division/office based in Mississauga.

Your Role

The Quality Assurance Specialist II, reporting to the QA Manager, 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 Wholesaling is applicable. You will complete branch Quality functions employing knowledge including: cGMP's, corporate guidelines, company work instructions, client SOP's, and all the applicable Health Canada regulations associated with the responsibilities performed at the assigned business unit(s) (e.g. narcotic control, controlled drugs and substances, precursors, etc.).

Your Responsibilities

• You will monitor the daily operational transactions of CDS (Controlled Drugs and Substances) /PCR (Precursor Control Regulations) products and fulfil regulatory reporting obligations per OCS (Office of Controlled Substances) regulations.
• Train and oversee level I staff as assigned
• You will inspect finished products and oversee the sampling of these products for testing and retention purposes in accordance to client or Kuehne+Nagel requirements.
• You will assist the flow of Operations including Inbound, Returns, Destruction, Outbound, Retention etc. where Quality support may be required.
• Support and participate in audit remediation activities
• You will release or quarantine product in accordance to client or Kuehne+Nagel instructions and regulatory requirements.
• You will support product complaint/inquiry requests or investigations in accordance to client or Kuehne+Nagel requirements.
• You will maintain site documentation control and record retention for all local forms, working instructions, profiles, customer SOP's, and client specific 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.

Your Skills And Experiences

• Canadian equivalency required if the degree was awarded outside Canada or the US.
• Basic knowledge of Quality Management systems and standards (i.e.: GMP, ISO 13485, ISO 9001).
• Experience with GMP's, GDP's, licencing, Federal and Provincial regulations.
• Bachelor in Sciences (e.g. Pharmacy, Chemistry, Biology, or a related discipline) is required.
• 3+ years industry experience in Medical Device/Pharmaceutical industry in QA. RA experienced may be considered 2+years industry experience in Medical Device/Pharmaceutical distribution.

Good Reasons to Join

We offer competitive compensation, a comprehensive benefits package, employee discounts, tuition reimbursement, excellent training programs and a highly dynamic global work environment. Kuehne+Nagel’s general working model is a hybrid model depending on the job location, function, etc. The working schedule specific details will be discussed in your job interview. Kuehne+Nagel reserves the right to change or adjust the working model policy.