Job Description

Our client is a Health Canada licensed distributor of medical grade liquid nitrogen providing on-demand and regular and continuous services to hundreds of clients across Ontario. Their on-site Quality Control and other experienced personnel present a personal level of experience, to provide the highest quality of product and cost-effective service.

The Quality Control Associate oversees the Q.A. department in quality related distribution activities, testing, and packaging/labelling of medical gas products to ensure full compliance with regulatory and safety requirements. This is an ideal opportunity for those with a few years of experience in Quality Assurance and regulatory affairs to advance their career in this multi-faceted role.

Major Responsibilities

• Maintain Drug Establishment License and Medical Device Establishment License by ensuring annual reviews are submitted on time, and coordinate with accounts personnel to issue payments.
• Host Health Canada audits, including Good Manufacturing Practices (GMP), Pharmacovigilance (GVP) and Medical Device audits, and provide corrective action reports for company management review.
• Provide scientific and/or regulatory advice to company management.
• Review QC related contract changes and amendments.
• Write, revise and maintain all Standard Operating Procedures (SOPs) on Medical Gas and Medical Device distribution related activities.
• Review and approve changes to labels, Certificate of Analysis, and other packaging/labelling documents to ensure compliance with regulations.
• Review and approve the investigation of customer complaints and non-conformance reports, manage reporting to the relevant regulatory authorities if necessary.
• Provide GMP and SOP training for technicians and QC designates.
• Perform GVP literature searches and maintain reports.
• Conduct internal audits to ensure regulations, safety requirements and internal SOP requirements are met. Provide audit report and suggest corrective actions for company management review.
• Maintain job descriptions and the organizational chart.

Other Responsibilities

• Maintain customer information and fill log databases in MS Access.
• Maintain filing system for all applicable quality records, including but not limited to testing records, distribution records, and maintenance records.
• Ensure that quality related records are maintained for required duration.
• Investigate or participate in the investigation of every complaint on quality or non-conformance that is received and implement corrective action if necessary. Notify the QC manager of the investigation per internal procedures.
• Conduct product testing as per internal Standard Operating Procedures (SOPs).
• Review and approve pertinent testing and production documents as per internal SOPs.
• Review and approve supplier Certificate of Analysis as per Internal SOPs.
• Release approved product for sale per internal SOPs.
• Monitor the maintenance of adequate segregation of products in the warehouse.
• Review sanitation documents per internal SOPs.
• Ensure all equipment used for QC testing is calibrated per internal SOPs.
• Review and approve all day-to-day packaging/labelling and distribution related documents.
• Ensure QC tags are securely stored, and that label sign out logs are completed accurately.
• Notify the QC manager of any returns, and implement any restocking if approved by the QC manager.
• Work with warehouse supervisor and technicians to ensure inventory related to licensed activities are maintained and equipment are calibrated per internal SOPs.
• Monitor other quality control related activities as per internal SOP requirements.
• Provide regulatory advice to customer accounts when required.

Qualifications

• Relevant industry experiences – at least two years preferred
• A diploma from a recognized post-secondary institution in regulatory affairs and quality control for health products is an asset
• A degree from a recognized post-secondary institution with acceptable specialization in sciences required

Hourly rate dependent on experience: $25/hour - $28/hour

Pension matching

Extended health benefits

Casual Dress

This position requires in-person attendance at the office.

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