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Biologics Manufacturing Quality Assurance Associate

Canadian Blood Services

This is a Full-time position in Calgary, AB posted July 14, 2019.

Join Canada’s Lifeline We’re seeking a Quality Assurance Associate to join our team in Calgary .

Be part of a dynamic, innovative, collaborative, diverse and caring organization committed to saving and improving the lives of Canadians.

We are the connection between the sincere generosity of donors, and the heartfelt appreciation of recipients.

Thousands of Canadians depend on our programs every day for reliable access to safe blood, plasma, stem cells, organs and tissues.

Are you ready to embark on a meaningful and inspiring journey, where what you do matters?

Be part of Canada’s lifeline.

Because we can all be the reason, the connection, that keeps Canadians living.

Must have minimum 5 years Quality Management in Continuous Improvement from the pharmaceutical environment following Good Manufacturing Practices As a member of Canadian Blood Services, furthers the Mission, Vision, Values and objectives of the organization in the delivery of products, processes and services that meet or exceed customer’s expectations in accordance with CBS’ Corporate Quality Policy.

As a partner to the business, the Quality Assurance Associate (QAA) provides the organizational assurance that we meet safety, quality, identity, purity, potency and accessibility requirements of our products and services.

The QAA plays an integral role that supports the business in delivering and improving products or services that meet the needs of our customers.

This position is also accountable for the Quality Management programs/processes/services.

The QAA develops and maintains partnerships with the business; understands their business needs and requirements, assists 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.

As a member of the Quality team, the QAA ensures 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 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, etc.) Champions the Quality System and its role in assisting Canadian Blood Services meet the needs of its customers.

Educates staff allowing them to better understand why Good Manufacturing Practices as defined by CBS’ Quality Management System, are necessary and how these principles apply to the activities CBS’ undertakes.

Assists the organization 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 other related duties as required.

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 require, or currently working on certification.

Ten years of experience within a manufacturing or pharmaceutical environment following Good Manufacturing Practices with at least 5 years of Quality Management I 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.

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 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 are required.

Ability to use Microsoft Office software is required.