Quality Assurance Associate

Canadian Blood Services•London, ON

3d•CA$86,400 - CA$101,700•Hybrid

About The Position

Canadian Blood Services is looking for a Temporary Full-time Quality Assurance Associate to join our dynamic Quality Assurance team, contributing to a broader, flexible role that spans national and local contexts. The Quality Assurance team is accountable for the systematic efforts taken to assure that all Canadian Blood Services’ products and services delivered to the customer meets expectations of the customer. In this role, you will be providing the organizational assurance that we meet safety, quality identity, purity, potency and accessibility requirements of our products and services. In this role, you will utilize your advanced knowledge of Good Manufacturing Practices (GMP), which includes Blood Regulations as defined by Health Canada, CSA Blood and Blood Component Standards as well as relevant Cell, Tissues and Organs (CTO) regulations and standards and the theory and application of quality systems elements to the products and services provided by Canadian Blood Services.

Requirements

Post-secondary level education in a relevant discipline from a recognized academic institution, or equivalent experience is required.
Certification in Quality Management Systems and/or certified Quality Engineer designation is required. Will consider an applicant currently working on certification, or an agreement to obtain certification.
Minimum of 7 years’ experience within a manufacturing, pharmaceutical or blood collections environment following Good Manufacturing Practices, with at least 5 years of Quality Management and Continuous Improvement experience.
Thorough comprehension of applicable standards and regulations and a comprehensive knowledge of the theory behind and application of quality systems processes as they pertain to the products and services provided by Canadian Blood Services (such as: Blood Collections, Health Canada's Blood and Blood component regulations, Canadian Standards Association's Blood and Blood component standards, Canadian Standards Association's Cells, Tissue, and Organ standards, AABB's Cellular Therapy standards, AABB's Blood Bank and Transfusion Services standards).
Comprehensive knowledge of Quality Management System elements is mandatory.
Comprehensive analytical, problem-solving and risk-based decision making skills are required.
Effective interpersonal skills along with proven ability to exercise sound judgment, tact and discretion, coach and facilitate discussions that promote the Quality Management System.
Strong ability to adjust and work in an agile work environment.
Demonstrated ability to think systemically and anticipate impact on people, systems and processes.

Responsibilities

Ensure the organization's products and services consistently meet requirements by maintaining control in manufacturing and donor centre processes, adhering to regulations and standards, and applying Quality System processes such as quality event management, document management, validation, change control, corrective action preventative action, auditing, training, quality control, etc.
Educate staff to enhance their understanding of Good Manufacturing Practices within Canadian Blood Services Quality Management System. This will clarify the necessity and application of these principles in the organization's activities.
Assist the organization in monitoring and continuously improving product and service quality. This involves collecting and analyzing data, facilitating root cause analysis, investigations, and overseeing the implementation of improvements.
Support any center and any QA department that requires coverage and support. This will require comfortability with adjusting time zones, hybrid work condition, travel and digital devices/tools for virtual connections and work execution.
Be connected and easy to reach during working hours and support the after-hours on-call (if required). This ensures timely and effective communication during critical situations and availability.
Perform local, national and other duties as required. This showcases your adaptability and versatility to contribute effectively across various tasks, sites and National Quality assurance department responsibilities within the organization.