Quality Assurance Specialist, Process

Centre de production de produits biologiques Inc; Montreal (administrative region); Hybrid; CAD 90,000 - 120,000; Full time

Benefits offered by this job

Flexible schedule

Remote work options

Competitive salary

Free on-site parking

Job summary

The Biologics Manufacturing Centre (BMC) Inc. in Montréal is seeking a Specialist, Quality Assurance - Process to lead product release activities for process intermediates, drug substances and drug products.

You will review COAs, batch records and related docs, issue certificates, and coordinate change controls and investigations to ensure GMP-compliant releases. The role requires a Bachelor's degree, 5+ years in GMP environments in pharma/biotech, and fluency in French with reading knowledge of

Qualifications

• Bachelor's degree in a relevant field.
• 5+ years of experience in a GMP-regulated pharmaceutical/biotech environment, including at least 1 year in finished product release.
• Ability to communicate effectively in French.
• Ability to read and understand technical documentation in English.
• Strong knowledge of quality standards, regulations and GMP guidelines.

Responsibilities

• Release products (process intermediates, drug substances, drug products) based on manufacturing activities and release timelines.
• Review Certificates of Analysis, batch records and related documentation for accuracy and compliance.
• Issue certificates (manufacturing/compliance certificates) and approve CoAs.
• Identify and assess deviations impacting product quality.
• Lead investigations to determine root causes of incidents with internal stakeholders.
• Prepare detailed investigation reports within established timelines.
• Coordinate change controls from approval through closure.
• Review and approve documentation for aseptic process simulations (Media Fill) and related records.
• Serve as a resource on GMP and GDP activities for stakeholders.

Skills

French language

English reading

Communication

Education

Bachelor's degree in a relevant field

Job description

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.

The BMC, an employer that offers what matters to you

• 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

The BMC, an organization unlike any other

• 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
• Our social mission is extraordinary

The BMC, a key player in Canadian biotechnology manufacturing

The BMC is a new facility located in the heart of Montréal, whose construction was completed in June 2021. It supports the expansion of Canada’s biologics manufacturing capacity, helping ensure that vaccines and other related products can be manufactured safely here at home. With its state‑of‑the‑art facilities and the expertise of its team, the BMC can manufacture biopharmaceutical products such as viral‑vector vaccines, protein‑subunit vaccines, virus‑like particle vaccines, and other biologics. It is a key contributor to Canada’s ability to respond rapidly to future national and global health emergencies.