QA Specialist Ii

5 days ago

Brampton, Canada Kuehne+Nagel Full time

We are looking for a Quality Assurance Specialist II for our Contract Logistics division/office based in Brampton.
- ** 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). #LI-Onsite
- ** Your Responsibilities**:

- You will assist the flow of Operations including Inbound, Returns, Destruction, Outbound, Retention etc. where Quality support may be required
- You will release or quarantine product in accordance to client or Kuehne+Nagel instructions and regulatory requirements
- 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 support product complaint/inquiry requests or investigations in accordance to client or Kuehne+Nagel requirements
- Maintain site documentation control and record retention for all local forms, working instructions, profiles, customer SOP's, and client specific documentation
- 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
- Support and participate in audit remediation activities

**Your Skills and Experiences**:

- 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
- Basic knowledge of Quality Management systems and standards (i.e.: GMP, ISO 13485, ISO 9001)
- Experience with GMP's, GDP's, licensing, Federal and Provincial regulations
- Bachelor in Sciences (e.g. Pharmacy, Chemistry, Biology, or a related discipline) is required
- Canadian equivalency required if the degree was awarded outside Canada or the US

**Good Reasons to Join **:We offer a great compensation package, medical, dental, and retirement benefits package, employee discounts, tuition reimbursement, excellent training programs and a dynamic global work environment.**A propos de Kuehne+Nagel***

Mit mehr als 80,000 Mitarbeitern an mehr als 1.300 Standorten in über 100 Ländern zählt Kühne+Nagel zu den global führenden Logistikdienstleistern.

Kühne+Nagel steht als Arbeitgeber für Chancengleichheit und wir engagieren uns auch im Hinblick auf Personen mit Behinderung für Diversität in unseren Teams. Wir glauben, dass Sie einen wertvollen Beitrag zu Kühne+Nagel leisten können und freuen uns auf Ihre Bewerbung.

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