Do you want to work in a dynamic, fast-paced, innovative organization? Are you excited about working with a dedicated community who makes a real difference in the lives of Canadians by recruiting blood, stem cell, cord blood and organ, eye and tissue donors? Do you want to help save lives every day? Then this job is for you.
Canadian Blood Services is a collaborative community of donors, volunteers, health care professionals, employees and corporate partners committed to saving and improving the lives of Canadians.
We are currently seeking a Quality Assurance Associate to join our team at head office (1800 Alta Vista Drive) in Ottawa.
In this role you will be a quality partner to the business; providing strategic input and ensuring that customer requirements for products and services are documented and met. You will be accountable for executing the Quality System processes that support the achievement of business objectives. You will develop and maintain partnerships with the business; understanding their business needs and requirements and assisting in assessing and identifying their quality needs, gaps, and requirements by providing subject matter expertise and advice on programs/processes and services aimed at improving quality. In addition you will ensure that work performed is consistent with the overall strategic direction of the Quality & Regulatory Affairs division and the organization as a whole and is accomplished by working in collaboration with other members of the division and/or other internal stakeholders.
Responsibilities include but are not limited to:
Developing and fostering effective day to day working relationships with all staff. Applying sound judgment, tact, discretion, and coaching to facilitate discussions that promote improvement.
Educating staff allowing them to better understand why Good Manufacturing Principles, as defined by CBS’ Quality Management System, are necessary and how these principles apply to the activities CBS’ undertakes.
Performing all quality system (Quality Event Management, Document Management, Validation, Change Control, CAPA, Quality Audits, Quality Training, etc.) activities according to established procedures and policies.
Independently monitoring and releasing products and services that comply with requirement/specifications.
Evaluating and reporting on the level of quality obtained and the level of compliance to requirement/specifications.
Leading the CAPA investigation process in collaboration with the business to establish root cause(s) and correct these cause(s).
Education, Training and Experience:
Degree in a related discipline from a recognized academic institution with an emphasis in quality management.
Certificate in Quality Management Systems and/or certified Quality Engineer designation is required, or currently working on certification.
A minimum of 5 years progressive experience in the quality assurance function of a pharmaceutical manufacturer, medical device or biological manufacturer following Good Manufacturing Practices is required.
Thorough understanding of applicable standards and regulations, a comprehensive understanding of the theory behind them and a knowledge of the 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.
Comprehensive understanding of statistical protocols and statistical analysis.
Effective interpersonal skills along with proven ability to exercise sound judgment, tact and discretion, coach and facilitate discussions that promote the processes within a Quality Management system.
Demonstrated ability to think systemically and anticipate impact on people, systems and processes.
Ability to work independently and with a team of high-performance professionals.
Strong written and verbal communication skills in English are required.
Ability to use Microsoft Office software is required.
We thank all applicants for their interest however only those selected for an interview will be contacted.
Do you want to work in a dynamic, fast-paced, innovative organization? Are you excited about working with a dedicated community who makes a real difference in the lives of Canadians by recruiting blood, stem cell, cord blood and organ, eye and tissue donors? Do you want to help save lives every day? Then this job is for you.Canadian Blood Services is a collaborative community of donors, volunteers..., health care professionals, employees and corporate partners committed to saving and improving the lives of Canadians.We thank all applicants for their interest however only those selected for an interview will be contacted.
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