Quality Auditor

About the role

Canadian Blood Services is looking for a Regular full-time Quality Auditor to join our dynamic Regulatory Affairs team. This position is posted nationally with a preference for candidates in Ottawa, Ontario. 

The Quality 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

• Bachelor's 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

• 4 weeks' 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 an on-site environment with requirements to be on-site at a Canadian Blood Services office for 40% of the time/2 days of the week. This requirement is subject to change based on operational needs.
• You 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.