Job Description

Please note this role will work in a hybrid environment. The successful candidate will be working a mixture of on-site and off-site work based on the parameters for our operations to meet the needs of our donors, our staff and our communities. Currently, this role is expected to have an in-person presence for at least 60% of their work time. This requirement may vary depending upon circumstances.#LI-HYBRID
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#LI-Manitoba\xe2\x80\x8bJob category: Quality and regulatory affairs
Job posting ID: 6244\xe2\x80\x8bEmployment status: Regular full-time
Possible schedule/FTE: 1.0
Number of positions available: 1Classification: PTS/MGT/IT B
Salary/Rate of pay: $78,895 - $92,638Application deadline: 2024-08-13
Application requirements:

• Your up-to-date resume.
• We recommend you save a copy of the job posting for reference throughout the recruitment process.

Do you currently work for Canadian Blood Services? All employees must apply via the .Together, we can make all the difference in the lives of others.Be part of a dynamic, collaborative and caring organization committed to saving and improving lives. Thousands of patients depend on us every day for reliable access to safe blood, plasma, stem cells and organs and tissues.If you are looking for a rewarding experience with a values and mission-driven team, join Canada\'s Lifeline and make a meaningful difference.We acknowledge that the work of Canadian Blood Services spans many Territories and Treaty areas across the country, and we are grateful for the Traditional Knowledge Keepers and Elders who have guided us in this important work. We recognize the land and waters that have inspired our work and offer gratitude to those Indigenous peoples on whose territory we work, live and play.About the role
Canadian Blood Services is looking for a Regular full-time Quality Assurance Associate to join our dynamic Quality Assurance team.The Quality Assurance team is responsible for the activities that are put in place to ensure the necessary level of confidence that all our products and services meet operational needs, quality requirements and satisfy all applicable legislative, regulatory, and standard requirements. The Quality Assurance team at Canadian Blood Services focuses on activities associated with our manufacturing environment and our clinical services environment.Formula for success

• Drawing on your knowledge and experience in quality assurance, you will provide 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.).
• Utilizing your excellent interpersonal and communication skills, you educate 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.
• Drawing on your attention to detail and ability to be proactive, you will assist 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.
• You will perform work in accordance with the provisions of the Canadian Blood Services\' Corporate Health and Safety Policies and Procedures.

Desired education and skills

• 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).
• 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.

What we offer you

• 4 weeks paid vacation
• Annual performance award up to 6%
• Comprehensive group health, dental and vision benefits for you and your family
• Defined benefit pension plan
• Employee discounts, wellness program, professional resources

What you can expect

• This role will work in a hybrid environment with requirements to be onsite at one Canadian Blood Services production site within Canada 60% of the time. This requirement is subject to change based on operational needs.
• You will work Monday to Friday, 8:00 am - 4:00 pm, however there is a requirement to participate in weekend and stat holiday rotation.
• Occasional travel may be required.

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.If this role resonates with you, we encourage you to apply by providing your up-to-date resume. 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 will be contacted. Applicants who require accommodation should discuss their needs with us.

Canadian Blood Services