CMO Quality Assurance Specialist

1 month ago


Kingston, Ontario, Canada Canopy Growth Full time
The Opportunity

We are seeking a highly organized and detail-oriented individual to join our quality team. If you possess sound judgment, excellent time management skills, and the ability to work collaboratively as part of a growing team, we encourage you to apply.

Responsibilities
  • Develop and deliver comprehensive training programs for new Quality Assurance team members on CMO procedures.
  • Collaborate with Quality Control, Regulatory Affairs, Operations, and Marketing departments to ensure compliance with Health Canada regulations and guidelines.
  • Lead the review and enforcement of Canadian and EU cGMP.
  • Develop and maintain Standard Operating Procedures that align with CMO initiatives, adhering to the Change Control procedure in the Quality Management System.
  • Track and trend lot release and KPI data.
  • Effectively communicate with managers and team members.
  • Compile and review CMO lot release reports.
  • Review CMO Transfer documents.
  • Participate in internal and external audits as required.
  • Work collaboratively with Manufacturing team members to improve processes and optimize productivity, ensuring timely responses to potential lot release impacts.
  • Support continuous improvement projects.
  • Perform other duties as assigned.
Experience
  • Degree or diploma in biology, biotechnology, pharmacology, or a related field (or equivalent working experience).
  • Working knowledge of Good Documentation Practices, Good Manufacturing Practices, and Cannabis Regulations is an asset.
  • Experience reviewing and revising regulated documents.
  • Experience working in an ISO:9001 or GMP environment is considered an asset.
  • Experience in a fast-paced working environment where time management, organization, and problem-solving were key skills.
  • Working knowledge of Microsoft Office suite of programs.
  • Experience with ERP systems (Sage or SAP) is considered an asset.
  • Strong verbal and written communication skills.


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