Senior Quality Assurance Specialist FL-QQ

4 weeks ago

Montreal, Canada Kuehne + Nagel AS Full time
Are you thinking about advancing your career with one of the most successful logistics organizations worldwide? Here at Kuehne+Nagel, our Montreal distribution site is looking for a new Senior Quality Assurance Specialist to join our Contract Logistics team. Your Role As the Senior Quality Assurance Specialist, you will assume responsibility for the ongoing support and maintenance of the Quality Management System at the local site level. Your role will be to execute branch quality functions employing your knowledge on cGMP's, corporate policies and guidelines, company work instructions, client SOP's, and all the applicable Health Canada regulations associated with the functions performed (e.g. narcotic control, controlled drugs and substances, precursors, etc.). You will report to the Quality Manager. Your Responsibilities
  • Perform adherence checks as applicable
  • Facilitate and/or Lead product complaint/inquiry requests, investigations and trending as per client or Kuehne+Nagel requirements
  • Monitor temperature conditions of the facilities if applicable review inbound product temperature conditions;
  • 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.
  • Facilitate deployment and development of training strategies
  • Train and oversee Level I and II staff as assigned
  • Support Operations in the maintenance of the site training program and applicable documentation;
  • Oversee and/or execute development and implementation of change controls, WI’s, and SOP’s using working knowledge of GMP’s and industry standards
  • Support the development of pro-active strategies as preventive measures against potential future issues within the QMS
  • Assist QA Manager with new client / product onboarding / setup preparation
  • Oversee day to day activities of QA Specialists, monitoring of work quality and productivity as assigned by the QA Manager
Your Skills and Experiences
  • Bachelor in Sciences (e.g. Pharmacy, Chemistry, Biology or a related discipline) is required
  • 5+ years industry experience in Medical Device/Pharmaceutical industry in QA
  • 3+ years industry experience in Medical Device/Pharmaceutical distribution site is preferred
  • Meet Health Canada's requirements to perform RPIC and QPIC responsibilities
  • Strong knowledge of Quality Management systems and standards (i.e: GMP, ISO 13485, ISO 9001)
  • Proficiency in French (written and verbal) an asset
Good Reasons to Join 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. #LI-ONSITE #J-18808-Ljbffr

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