Senior Specialist, Quality Assurance
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Job Description
Senior Specialist, Quality Assurance handling temperature management responsibilities across Canadian distribution centers. Leading quality initiatives and overseeing compliance in pharmaceutical distribution.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- Bonus eligible: Yes
- Performance-based annual bonus
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