Quality Assurance Specialist

Groupe-3dm; Pointe-Claire; On-site; CAD 26,000 - 42,000; Part time

Benefits offered by this job

Flexible schedule

Part-time position

Job summary

3DM Group in Pointe-Claire, QC is seeking an experienced QA Specialist to join on a permanent part-time basis (approximately 20-25 hours per week). The role focuses on overseeing quality assurance, regulatory compliance, audits, and CAPAs for pharmaceutical clients.

You will work cross-functionally to maintain SOPs, QA documentation, and supplier qualifications, with Health Canada GMP requirements in scope. Strong language skills in French and English are required.

Qualifications

• Minimum of 5 years of experience in Quality Assurance and/or Compliance.
• Bachelor's degree in a science-related field.
• Experience in pharmaceutical distribution, warehousing, logistics, or another regulated environment.
• Proficiency in Microsoft Office and general computer applications.

Responsibilities

• Establish, maintain, and monitor quality standards, systems, SOPs, and controlled docs.
• Ensure adherence to client SOPs, TQAs, and quality requirements.
• Comply with Health Canada, GMP, pharmaceutical, and other regulations.
• Conduct internal audits and coordinate client and regulatory audits.
• Investigate deviations, CAPAs, and non-conformances; perform root-cause analysis.
• Oversee QA activities including change control, recalls, and retention samples.
• Maintain quality documentation, renewals, and compliance activities.
• Monitor regulatory updates and communicate internally.

Skills

Quality assurance

Regulatory compliance

Communication skills

Bilingual French-English

Organizational skills

Education

Bachelor's degree in a science-related field

Tools

Microsoft Office

Job description

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.