Quality Assurance Assistant - North York, Canada - Peak Performance Human Resources Corp.

Peak Performance Human Resources Corp.

Verified Company

North York, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

N-Two Medical Inc. is a Health Canada licensed distributor 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 Coordinator oversees quality related distribution activities, testing, and packaging/labelling of medical gas products to ensure full compliance with regulatory and safety requirements.

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 nonconformance 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 daytoday 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.

Some Internal Sales Responsibilities

Build and maintain relationships with current and prospective customers.
Provide service recommendations to customers and management.
Write and provide quotation to prospective customers.
Review and complete requests for quotation from procurement companies.
Write marketing descriptions and participate in marketing material design to represent company at industry conferences when required.
Manage nonquality control related complaints.
Schedule on demand and regular customer deliveries. Coordinate the scheduling with medical delivery techs.
Process invoices and payments with Simply Accounting when needed

Qualifications

Relevant industry experiences
A diploma from a recognized postsecondary institution in regulatory affairs and quality control for health products.
A degree from a recognized postsecondary institution with acceptable specialization in sciences.

Job Types:
Full-time, Permanent

Salary:
From $45,000.00 per year

Benefits: