Job Description

Please note: This is a hybrid position; the successful incumbent must be located near a Canadian Blood Services production facility.
Job category: Quality and regulatory affairs
Job posting ID: 3412
Employment status: Temporary full-time
Position's anticipated end date: 2023/06/18
Classification: PTS/MGT/IT B
Salary/Rate of pay: $63,600 to $75,525
Application deadline: 2022-08-29
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 Temporary Full-Time Validation Associate to join our dynamic Quality Assurance team. The work of Validation Associate is integral to Canadian Blood Services role as Canada’s Lifeline.
In this role, you will support the development, execution, and continuous improvement of the Canadian Blood Services’ validation program by contributing to the development and continuous improvement of procedures and tools that meet Canadian Blood Services’ Quality requirements, and effectively contribute to the safety of recipients who rely on quality products and services.
You will provide technical and regulatory guidance to the user community, provide subject matter expert support on project teams, assess validation requirement and lead validation efforts that may include validation project planning, validation document development, and validation execution. You will also support the control and maintenance of validation records, as quality records within the Quality Management System.
Key responsibilities include:

• Develop and improve validation processes and procedures through generation and revision of procedures and tools.
• Develop, maintain, and improve document templates in support of a standardized validation program.
• Ensure that processes and procedures comply with current regulations and Canadian Blood Services policies and requirements.
• Participate in the establishment and implementation of a training program for the validation program.
• Provide subject matter expertise and guidance to Canadian Blood Services’ process user community to promote consistency in the application of validation principles across the organization.
• Develop validation deliverables as required including, but not limited to, validation plans, validation protocols, study documents and validation summary documents.
• Consult and work with the process user community in all divisions to ensure that the validation processes, procedures, and support tools meet user needs.
• Participate in the development and collection of process performance monitoring metrics to effectively monitor, manage, and continuously improve the national validation program.
• Partake and contribute in assigned roles as defined in related Quality Management System processes, including Quality Event Management, Change Control, Document Management, CAPA, etc.
• Liaise and consult with other Canadian Blood Services sites, departments, and staff to share knowledge and promote team culture.
• Perform other related duties as required.

Education, Training and Experience:

• Post-secondary level education in a relevant discipline from a recognized academic institution, preferably a university degree in Engineering or Sciences, or equivalent professional education.
• Three to six years of related experience in validation and quality management systems, process design and control.
• Experience working a in pharmaceutical, medical device or biologic manufacturing environment under GMP regulation is essential.
• Thorough understanding of the theory and application of validation processes and principles.
• Experience with writing and executing validation plans, generating and executing test protocols and preparing validation reports is required. Specific experience in validation of facilities, manufacturing and laboratory equipment, computerized systems, software, processes, and methods, is considered a strong asset.
• Knowledge of accreditation requirements of organizations, such as AABB, OLA and FACT is considered an asset.

Demonstrated Skills and Abilities:

• Demonstrated analytical, problem solving and strong decision-making skills are required.
• Sound organizational and management skills are required.
• Ability to balance multiple priorities.
• Ability to work independently and under significant timeline pressures.
• Ability to quickly learn the business in unfamiliar areas.
• Ability to work on cross-functional teams.
• Proven effective interpersonal, facilitation and English language communication skills.
• Effective writing skills with the ability to quickly produce clearly written, well-organized documentation and presentations.
• Ability to use Microsoft Office is required.

Benefits:

• Competitive base salary.
• Payments in lieu of vacation, holidays, and benefits.
• Annual Performance Award up to 6%.
• Flexible hybrid work schedule.
• Choice of defined contribution or defined benefits pension plan.
• Employee discounts, wellness programs, 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.
To protect the health and safety of its employees, all Canadian Blood Services’ employees are required to be fully vaccinated (COVID-19 vaccine doses as approved by Health Canada), subject to any medical or other human rights grounds. 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.