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Quality Assurance Assistant

2 weeks ago

North York, Canada Peak Performance Human Resources Corp. Full time

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 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.

**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 non-quality 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 post-secondary institution in regulatory affairs and quality control for health products.
- A degree from a recognized post-secondary institution with acceptable specialization in sciences.

**Job Types**: Full-time, Permanent

**Salary**: From $45,000.00 per year

**Benefits**:

- Dental care
- Extended health care
- Life insurance

Schedule:

- Monday to Friday
- On call
- Weekend availability

Ability to commute/relocate:

- North York, ON: reliably commute or plan to relocate before starting work (required)

Application question(s):

- Do you have Regulatory Affairs experience?
- What is your hourly salary requirements?

**Education**:

- Bachelor's Degree (preferre