Quality Assurance Specialist

3DM Group has been a leader in logistics, fulfillment, and supply chain management for E-Commerce and pharmaceutical companies for over 30 years. We pride ourselves in providing the fastest and most cost-effective delivery of clients’ goods to consumers in order to maximize their experience.

The company is on a mission of growth and modernization of technology platforms targeting a better experience for our customers in the coming years. We are looking for an experienced QA Specialist to join us on a permanent part-time basis at our Pointe-Claire office. This position offers a flexible schedule of approximately 20–25 hours per week.

The QA Specialist is responsible for overseeing and maintaining 3DM Group’s quality assurance and compliance activities, ensuring adherence to company standards, client requirements, and applicable regulations. The role works cross-functionally with departments to maintain quality systems, identify risks and quality concerns, and ensure appropriate corrective actions are implemented.

Responsibilities and duties include, but are not limited to:

• Establish, maintain, and monitor company quality standards, quality systems, SOPs, work instructions, training records, and controlled documentation.
• Manage adherence to client-specific SOPs, Technical Quality Agreements (TQAs), and quality requirements.
• Ensure compliance with applicable Health Canada, GMP, pharmaceutical, and other regulatory requirements.
• Conduct internal audits and facility inspections and coordinate client and regulatory audits.
• Investigate deviations, complaints, temperature excursions, quality issues, and other non-conformances; conduct root-cause analysis and oversee CAPAs.
• Oversee pharmaceutical QA activities including change control, recalls, quarantine, product destruction, retention samples, and temperature-controlled activities.
• Maintain required quality and regulatory documentation, records, renewals, and compliance activities.
• Ensure applicable GMP-related preventative maintenance programs and quality requirements are followed.
• Support supplier qualification and monitoring in accordance with applicable QA standards and procedures.
• Monitor changes to applicable regulatory requirements and communicate relevant updates internally.
• Support client quality and compliance requirements, including audits, questionnaires, documentation requests, and onboarding activities.
• Ensure quality management reports are reviewed with management and alert the COO and/or President of significant quality or compliance concerns.

Maintain an annual Quality Management Plan with a focus on continuous improvement.

• Minimum of 5 years of experience in Quality Assurance and/or Compliance.
• Bachelor’s degree in a science-related field, in accordance with applicable Health Canada requirements.
• Experience in pharmaceutical distribution, warehousing, logistics, or another regulated environment.
• Strong knowledge of quality systems, SOPs, audits, CAPAs, root-cause analysis, and regulatory compliance.
• Knowledge of Health Canada regulations and GMP requirements.
• Excellent communication and organizational skills.
• Excellent attention to detail and accuracy.
• Proficiency in Microsoft Office and general computer applications.
• Bilingual in French and English, both written and spoken.
• Ability to manage priorities and work both independently and collaboratively across departments.