
Quality Assurance Associate
City : Brampton, ON
Category : Quality and regulatory affairs
Industry : Charitable Organizations
Employer : Canadian Blood Services
Please Note: We work in a hybrid environment, to ensure we continue to meet the needs of our donors, our staff, and our communities we are required to have in-person presence for a minimum of 3 days a week. This role is located in Brampton, Ontario.
Job category: Quality and regulatory affairs
Job posting ID: 4528
Employment status: Regular full-time
Classification: LT OPSEU 200
Salary/Rate of pay: 36.15
Application deadline: 2023-06-02
Do you currently work for Canadian Blood Services? All employees must apply via the internal career page.
Somewhere in Canada there’s a life you can save.
Be part of a dynamic, collaborative and caring organization committed to saving and improving the lives of Canadians. Thousands of Canadians depend on us every day for reliable access to blood, plasma, stem cells and organs and tissues.
Join Canada’s Lifeline and make a meaningful difference every day.
About The Role:
Canadian Blood Services is looking for a Regular Full-Time Quality Assurance Associate to join our dynamic Quality Assurance Team in Brampton, Ontario. In this role, you will provide the organizational assurance that we meet safety, quality, identity, purity, potency and accessibility requirements of our products and services. You must have a thorough understanding of, applicable Good Manufacturing Practices (GMP). This 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 system elements to the products and services provided by Canadian Blood Services.
Key Responsibilities Include:
- Provides the organization assurance that our products and services consistently meet requirements by ensuring a state of control in our manufacturing and clinical services processes and overall compliance with regulations and standards, and the appropriate application of Quality System processes (i.e., document management, validation, change control, corrective action preventative action, auditing, training and quality control, quality event management etc.)
- Educates staff allowing them to better understand why Good Manufacturing Practices as defined by Canadian Blood Services' Quality Management System, are necessary and how these principles apply to the activities Canadian Blood Services undertakes.
- Assists the organization to monitor and continuously improve the quality of its products and services by collecting and analyzing data and facilitating root cause analysis, investigations and monitoring improvements.
- Performs work in accordance with the provisions of the Canadian Blood Services' Corporate Health and Safety Policies and Procedures.
Education, Training and Experience:
- Post-secondary degree in a related discipline from a recognized academic institution.
- Certificate in Quality Management Systems and/or certified Quality Engineer designation is required, or currently working on certification.
- Ten years of experience within a Biologics manufacturing or pharmaceutical environment following Good Manufacturing Practices with at least 5 years of Quality Management and Continuous Improvement experience.
- Thorough understanding of applicable standards and regulations and a comprehensive understanding of the theory behind and application of quality system processes as they pertain to the products and services provided by CBS (such as: 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).
Demonstrated Skills and Abilities:
- Comprehensive knowledge of Quality Management System elements is required.
- Comprehensive analytical, problem-solving and 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.
- Demonstrated ability to think systemically and anticipate impact on people, systems and processes.
Benefits
- 3 weeks of paid vacation
- Comprehensive group health, dental and vision benefits
- Defined Benefits Pension Plan
- Employee discounts, wellness program, and much more
Diversity and inclusion play a vital role in ensuring health equity for patients across Canada. We are committed to reflecting Canada’s population in our organization and fostering an environment where all employees can be their authentic selves, with equal opportunities to succeed and contribute.
Canadian Blood Services requires that all employees be fully vaccinated (COVID 19 vaccine doses as approved by Health Canada), subject to any medical or other human rights considerations. Persons who have been vaccinated outside of Canada must contact their local Public Health Unit in order to obtain a vaccine equivalency certificate.
If this role resonates with you, we encourage you to apply! This could be your first step towards a meaningful and inspiring career. Come to work each day knowing that you save lives.
We thank all applicants for their interest. However, only those considered for an interview or those invited to participate in an assessment (such as testing) will be contacted. Applicants who require accommodation should discuss their needs with us.