Quality Assurance Analyst

N-Two Medical Inc. is a Health Canada licensed distributer of medical grade liquid nitrogen. We provide on-demand as well as regular and continuous services to over 600 clients across Ontario. Our on-site Quality Control and other experienced personnel present a personal level experience, to provide the highest quality of product and cost-effective service.The Quality Assurance Associate oversees quality related distribution activities, testing, and packaging/labelling of medical gas products to ensure full compliance with regulatory and safety requirements.Job Summary: The successful candidate will oversee quality related packaging/labelling and distribution activities of medical products to ensure full compliance with regulations and safety requirements.Key Responsibilities• Manage customer accounts to provide regulatory advice and service recommendations.• Maintain customer usage database on MS Access.• Review and approve of labels, Certificate of Analysis, and other packaging/labelling documents to ensure compliance with regulations.• Maintain Drug Establishment License and Medical Device Establishment License by ensure annual reviews are submitted on time, and coordinate with accounts personnel to issue payments.• Host Health Canada audits, including Good Manufacturing Practices (GMP), Pharmacovigilance and Medical Device audits.• Write, revise and maintain all Standard Operating Procedures (SOPs) on Medical Gas packaging/labelling and distribution as well as Medical Device distribution.• Provide GMP and SOP training for technicians and customers.• Report and manage customer complaints; initiate non-conformance reports, participate in root cause analysis when required, and implement corrective and preventative actions.• Conduct internal audits to make sure regulations, safety requirements and internal procedures are met.• Maintain filing system for all quality records, including but not limited to distribution logs, maintenance logs, label Logs, receipt logs, and quotes.• Work with supervisor and technicians to ensure inventory related to activities are maintained.Educational Requirements:• Bachelor of Science• Pharmaceutical RAQC• Canadian and International Regulatory Affairs and Quality Control• The Food and Drug Act and Regulations, labels and GMP’s*Can be a graduate with experience, co op, at least 2-yrs relevant industry experience.Location:                   North York, OntarioType:                          Full-time, Onsite | Monday–Friday, 8:30am–5:00pmCompensation:          $60-$63K/yr (based on meeting all experience requirements)