Design Quality Specialist
Location
Ottawa, ON | Canada
Job description
Please note this role will work in a hybrid environment. The successful candidate must be located near a Canadian Blood Services site and 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, employees are expected to have an in-person presence for at least 40% of their work time. This requirement may vary depending upon circumstances.
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Job category: Quality and regulatory affairs
Job posting ID: 5630
Employment status: Regular full-time
Position's anticipated start date: 2024-05-27
Classification: PTS/MGT/IT B
Salary/Rate of pay: $87,000 - $105,000
Application deadline: 2024-03-17
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 internal career page .
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 Design Quality Specialist to join our dynamic Quality Assurance team.
The
Quality Assurance team is accountable for the systematic efforts taken to assure that all Canadian Blood Services’ products and services delivered to the customer meets expectations of the customer.
Reporting to the Associate Director, Quality Assurance, you, as the Design Quality Specialist, will offer subject matter expertise in quality by design to product and process development teams. Your responsibilities will encompass all aspects of quality assurance throughout the design, development, design transfer, and design changes of Canadian Blood Services products. Additionally, you will provide support in areas such as design requirement development, design verification and validation, design transfer, and risk management. Your active participation and support will extend to design changes and post-launch surveillance activities, with a primary focus on ensuring the quality of documentation and processes across the various phases of the product and process development life cycle.
Formula for success
- Leveraging your skills and experience in regulatory compliance, you will interpret quality by design principles and requirements described in standards, regulations, and/or industry best practices.
- Utilizing your skills in quality by design principles and product/process development, as well as utilizing your collaboration and documentation management skills, you will provide expertise and support for product and process development while working with the process owner to develop, update, and maintain the technical content of design history files.
- Drawing on your collaboration and documentation management skills, you will work with the process owner to develop, update, and maintain the technical content of risk management files.
- Applying your teamwork and risk management skills, you will collaborate with teams to conduct robust risk assessment reviews, ensuring all relevant risks are appropriately identified, evaluated, mitigated, and documented.
- Capitalizing on your collaboration and process improvement skills, you will work with the quality management system team in the development, maintenance, and improvement of work instructions, reference materials, and tools required to operationalize the Quality by Design process.
- Utilizing your educational and communication skills, you will educate process teams about quality by design in the context of the quality management system, ensuring roles, responsibilities, and value propositions are understood.
- Employing your interpersonal and leadership skills, you will develop, promote, and facilitate effective working relationships with Canadian Blood Services staff through expertise and guidance, enabling the organization to understand the Quality by Design requirements in biologics manufacturing and clinical services.
Desired education and skills
- University Degree in Engineering or Life Sciences or in a relevant discipline from a recognized academic institution, or equivalent work experience. ASQ Certification as a CQA, CQE, or CMQ/OE would be an asset.
- At least 10 years of progressive related experience within a manufacturing (Pharmaceutical, Medical Device, Biologics or related) environment, with at least 5 years of relevant experience in quality assurance and quality by design.
- Ability to generate internal quality documentation such as design specifications, risk management plans, quality plans, validation and verification Protocols and Reports.
- Experience using quality tools and statistical programs (e.g., risk assessment (FMEA), experimental design (DOE) and statistical process control (SPC) is required.
- Strong collaboration skills, with ability to influence and build strong relations and liaise effectively with various business groups.
- Strong organizational skills as well as time management skills essential for project work.
- Effective communication skills including verbal and written skills, with the ability to quickly produce clearly written, well-organized documentation and presentations.
What we offer you
- 4 weeks' vacation
- Annual performance award up to 8%
- 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 of our Canadian Blood Services locations, at minimum 40% of the time.
- Travel requirements - travel will be required to attend team meetings and project commitments.
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 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.
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