Quality Auditor

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 at 1800 Alta Vista Drive Ottawa Ontario 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.

Job category: Quality and regulatory affairs
Job posting ID: 8032

Employment status: Temporary full-time
Positions anticipated start date:
Positions anticipated end date:

Classification: PTS/MGT/IT B
Salary/Rate of pay: $80078 - $94028

Application deadline:

• This external job posting may close earlier than the advertised deadline. We recommend applying as soon as possible.

Application requirements:

• Your up-to-date resume.
• Cover letter
• 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 Canadas 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 aTemporary Full-time Quality Auditor to join our dynamicQuality and Regulatory Affairs team in Ottawa Ontario.

TheQuality and Regulatory Affairs division is responsible for providing daily support and subject-matter expertise to Canadian Blood Services in regulatory and quality matters helping the organization to thrive as a biologics manufacturer and provider of transfusion and transplantation services.

Reporting to the Manager Quality Audits you will provide auditing expertise for the Canadian Blood Services Audit Program including internal and supplier audits. You will help ensure that Canadian Blood Services consistently meets safety quality identity purity potency and accessibility requirements for our products and services as well as the safety of our donors and patients.

In this role you play an integral part in supporting continual improvement across the organisation. You will monitor compliance with regulatory and Canadian Blood Services requirements report on the state of control and identify risks to products and services. You will also identify gaps in the quality management system and provide expert advice on programs processes and services designed to enhance quality.

Through the Supplier Qualification Program including supplier audits you will help ensure that products and services provided to Canadian Blood Services are consistently available and meet our high standards. As a member of the Quality team you will ensure your work aligns with the strategic direction of the Quality & Regulatory Affairs division and the organisation as a whole.

Formula for success

• Leading audit preparation and design you will contribute to the development implementation maintenance and documentation of audit processes and functions.
• Leveraging your expertise in supplier oversight you will provide accountability and guidance within the externally focused Supplier Audit Program and the Supplier Qualification Program.
• Drawing on your analytical skills you will complete risk management analyses to support the development of the Quality Audits Schedule including both Quality Assurance and Supplier Audits.
• Preparing and reviewing audit reports you will summarise findings both text and graphical to support trending analysis and compliance assessments.
• Presenting critical quality data you will prepare audit information for Quality Assurance and senior leadership supporting Corporate Management System Review discussions at the Executive Management Team (EMT) level.
• Identifying system and process deficiencies you will assess impacts across CBS manufacturing processes in alignment with Health Canada regulations USFDA GMP the Canadian Nuclear Commission Provincial Ministries of Health and the Environment and CBS standard operating procedures.
• Serving as a leadership designate you will act on behalf of the Manager Quality Audits when required.
• Leveraging your adaptability you will perform other duties as required.

Desired education and skills

• Bachelors Degree (biology chemistry microbiology immunology medical technology) or Engineering Degree in Electronic/Electrical/Mechanical or Information Technology.
• Three to six years of progressive related experience relevant to the functions of a Quality Auditor in a Biologics Pharmaceutical Medical Devices or health-related regulated environment.
  Incumbents must have a certificate of Audit Designation from a recognized Institute. Experience/Knowledge or training in the following: Blood Centre Operations and/or blood banking Canadian and US Regulatory Standards for GMP GDP GLP FDA requirements for Medical Devices Information Technology Environmental Management Systems ISO/TQM/CQI/SPC/QSIT/ICH.
• Experience working in IT or quality control lab is an asset.
• Knowledge of Canadian and US regulatory requirements pertaining to the auditing functions for the collection of blood and the manufacture of blood/blood components as well as for the manufacture of medical devices.
• An understanding of the application of standards in a pharmaceutical manufacturing model.
• Proficient in writing and editing technical documents.
• Exercise good and ethical judgement related to all audit activities and must have the ability to manage meetings of the audit team and between the audit team and customers and to assess situations related to potential problems conflicts of audit activities and to take appropriate action remaining diplomatic at all times.

What we offer you

• Percentage in lieu of benefits and vacation.
• Annual performance award up to 6%.
• 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 Canadian Blood Services office 1800 Alta Vista Drive Ottawa Ontario 40% of the time/2 days of the week. This requirement is subject to change based on operational will work Monday to Friday 37.5 hours per week 7.5 hours a day.
• The role includes a travel component of approximately 30% or more as required which may be national or international for audit purposes.

Diversity and inclusion play a vital role in ensuring health equity for patients across Canada. We are committed to reflecting Canadas 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. Emails are sent directly from our system to ensure you receive them please add and to your safe senders list.

Applicants who require accommodation should discuss their needs with us.

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