Quality Control Associate

Shine Talent Solutions

Toronto

On-site

CAD 34,440 - 38,572

Full time

14 days+

Get more replies from employers

Send a job-specific resume in minutes.

Job summary

An established industry player is looking for a Quality Control Associate to join their team in Ontario. This entry-level position offers a unique opportunity to work in a dynamic environment, overseeing quality assurance activities for medical gas products. You will play a crucial role in maintaining compliance with regulatory standards, conducting audits, and providing training. If you have a passion for quality control and regulatory affairs, this position is perfect for you to advance your career while contributing to the health sector's integrity. Join a team that values your expertise and dedication to quality.

Qualifications

At least two years of relevant industry experience preferred.
Degree in sciences required for this role.

Responsibilities

Oversee quality control activities, ensuring compliance with regulations.
Host Health Canada audits and provide corrective action reports.
Conduct internal audits and provide training for technicians.

Skills

Quality Assurance

Regulatory Affairs

Good Manufacturing Practices (GMP)

Good Vigilance Practices (GVP)

Scientific Advice

Education

Diploma in Regulatory Affairs and Quality Control

Degree in Sciences

Tools

MS Access

Job description

Get AI-powered advice on this job and more exclusive features.

Shine Talent Solutions provided pay range

This range is provided by Shine Talent Solutions. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

CA$25.00/hr - CA$28.00/hr

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

This position requires in-person attendance at the office.

Seniority level