Lead and coordinate temperature mapping studies across Canadian distribution centers, including vendor collaboration, sensor setup, data collection, analysis, and report preparation
Manage temperature excursions and warehouse deviations; partner with Operations to investigate root causes and implement corrective actions
Administer change controls related to temperature-controlled storage areas
Monitor and respond to on-site alarm notifications in partnership with Operations
Oversee temperature excursions during transportation, gather required investigation data, and work with suppliers to assess product impact
Collaborate with Transportation and Operations to investigate issues and implement corrective/preventive measures
Conduct temperature-related qualification studies (e.g., lane qualification) as needed
Serve as the Subject Matter Expert (SME) for Temperature Management during internal and external audits
Support temperature management programs for Pharmaceutical and Medical Distribution
Develop, update, and maintain temperature management Standard Operating Procedures (SOPs)
Manage calibration programs for critical-to-quality equipment

Bachelor of Science degree
considered an asset
Minimum of 2-4 years’ experience in Quality within the medical device, pharmaceutical, or related industry, preferred
Applied knowledge of the Health Canada Food and Drug Act, Canadian Medical Devices Regulations, Drug Regulations and GMP, Natural Health Product Regulations, Cosmetics and Consumer Regulations
Strong understanding of GUI-0069 and USP requirements
Highly organized with strong analytical and problem‑solving abilities
Skilled communicator (verbal, written, and presentation)
Ability to interpret technical data, summarize insights, and prepare clear reports
Effective cross‑functional collaborator with internal teams, vendors, and customers
Strong computer skills including, Word, Excel, SharePoint and PowerPoint

Senior Specialist, Quality Assurance

Key skills