Quality Assurance Specialist, Process

The Biologics Manufacturing Centre (BMC) Inc. is a new biomanufacturing facility created in response to the pandemic. As a non-profit organization, the BMC aims to better meet the biopharmaceutical needs of Canadians. The BMC supports projects of public interest, actively contributes to the growth and overall resilience of Canada's life sciences industry, and fosters industry development and innovation through domestic manufacturing.

Driven by its engaged and innovative employees, the BMC promotes a culture of agility and transparency, with a collaborative and results-oriented approach.

We are seeking a Specialist, Quality Assurance
- Process who will be responsible for product release activities (process intermediates, drug substances, and drug products) to ensure product quality and compliance. In this role, the person will evaluate deviations, participate in investigations, coordinate change controls, and recommend corrective and preventive actions.
This is a temporary assignment of approximately 13 months to cover a leave of absence.

The Specialist, Quality Assurance
- Process will have the following responsibilities:

• Release products (process intermediates, drug substances, and drug products) based on manufacturing activities and release timelines.
• Review all associated documentation (e.g., Certificates of Analysis, batch records, etc.) to confirm accuracy and compliance.
• Issue applicable certificates (manufacturing and compliance certificates) and approve product Certificates of Analysis.
• Identify and assess deviations that may impact product quality.
• Lead quality event investigations in collaboration with internal stakeholders to determine root causes of incidents.
• Prepare detailed investigation reports within established timelines to ensure compliance with procedures and customer delivery commitments.
• Lead risk prevention initiatives (e.g., quality-focused GEMBA walks).
• Coordinate change controls from approval through closure.
• Review and approve documentation associated with aseptic process simulations (Media Fill), including production batch records, protocols, and validation reports.
• Serve as a resource person for all stakeholders involved in the product release process and for employees participating in GMP and GDP-related activities.
• Occasionally perform incoming material release activities (raw materials, process consumables, production support items, packaging components, etc.) based on supply and production requirements.
• Occasionally approve Certificates of Analysis (CoAs) issued for laboratory testing activities during periods of peak production.

• You hold at least a Bachelor's degree in a relevant field.
• You have a minimum of five (5) years of experience in a GMP-regulated environment within the pharmaceutical or biotechnology industry, including at least one (1) year of experience in finished product release.
  • An equivalent combination of education and relevant experience may be considered.
• You are able to communicate effectively in French.
• You are able to read and understand technical documentation in English.
• You have a strong knowledge of quality standards, regulations, and GMP guidelines.

• A flexible schedule and remote work options
• A competitive salary aligned with your skills
• A culture of transparency, including monthly corporate meetings
• A respectful and welcoming work environment
• A new facility equipped with state-of-the-art technology
• An opportunity to participate in our various workplace committees (social club, employee committee, occupational health and safety committee, etc.)
• A wide range of activities throughout the year to connect with colleagues, celebrate team successes, and expand your knowledge
• Free on-site parking

• Our team is made up of talented and dedicated people from diverse backgrounds
• We strive to develop, share, and disseminate knowledge
• Our non-profit status allows us to reinvest every dollar of profit in the organization
• Our people-focused size allows every employee to help shape the organization’s growth
• Our economic positioning is unique within our industry