Quality Assurance Analyst

2 weeks ago

Vaughan, Ontario, Canada N-Two Cryogenic, Inc Full time

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, Ontario

Type:
Full-time, Onsite | Monday–Friday, 8:30am–5:00pm

Compensation:

 $60-$63K
/yr (based on meeting all experience requirements)

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