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Quality Assurance Specialist in Pointe-Claire, Quebec at Groupe 3DM

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Groupe 3DM
Pointe-Claire, Quebec, H9R 5W5, Canada
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Job Description

Our Company:

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.

Job Description:

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.

Duties/Responsibilities:

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.

    Skills and Requirements:

  • 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.

    • Job Location

    Pointe-Claire, Quebec, H9R 5W5, Canada

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