Specialist,QC Systems Job Vancouver area,BC Canada,Quality Assurance

Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown.

As the Specialist, QC Systems, you will support the design, implementation, and ongoing management of the Quality Management System (QMS) for QC-related CMC/GMP activities. Your role will play a critical part in ensuring the effective implementation, execution, and continuous improvement of the QMS framework within AbCellera, while maintaining compliance with applicable global regulations and regulatory expectations.

You will ensure that the QC laboratory electronic systems (eSystems) are fit-for-purpose, compliant, and enable efficient, data-driven laboratory operations. Working cross-functionally, you will help foster a strong culture of quality across the CMC/GMP organization. You will be empowered with a high degree of ownership and autonomy to innovate, move quickly, and build scalable quality and digital capabilities that leave a lasting impact on our organization and industry.

How you might spend your days

Supporting, maintaining, monitoring, and continuously improving the QC Quality Management System (QMS) framework and associated quality system processes in compliance with applicable global CMC/GMP requirements

Supporting the operation, administration, and lifecycle management of QC laboratory electronic systems (eSystems), ensuring they effectively support sample management, analysis, data acquisition, data review, and result reporting in compliance with global GMP, data integrity, and regulatory requirements

Contributing to the design, implementation, and evolution of the QC data architecture, identifying eSystem capabilities needed to support QC workflows, data integrity (ALCOA++), and phase-appropriate compliance

Supporting the Business Process Owner (BPO) for QC laboratory systems (e.g. LIMS, LES, CDS), overseeing system changes, enhancements, and upgrades throughout the system lifecycle

Overseeing and maintaining QC eSystems master data, including user roles, permissions, system configurations, and controlled data objects

Developing, reviewing, and maintaining GMP procedures, work instructions, controlled documentation, and training materials governing the compliant and effective use, administration, and data management of QC eSystems, including delivery of end-user training sessions

Providing QC eSystem support for investigations, deviations, and CAPAs, including data retrieval, audit trail review, and system impact assessments

Supporting qualification and computer system validation activities for QC systems (e.g., protocol and risk assessment review, validation deviations/exceptions, and lifecycle documentation)

Supporting QC eSystem licensing, user access, vendor relationships, and budgeting/forecasting for QC digital infrastructure

Collaborating cross-functionally with QC, Quality Systems, IT, Engineering, Validation, and external vendors to ensure QC eSystems are fit-for-purpose, compliant, and aligned with laboratory and business processes

We’d love to hear from you if

You have 3+ years of experience managing quality systems in a GxP-regulated environment, with demonstrated application of global CMC/GMP requirements and relevant regulations and guidance

You have a Bachelor’s degree in a relevant scientific or engineering discipline with 5+ years of industry experience in biotechnology, pharmaceuticals, or life sciences

You have strong understanding and hands-on experience with quality management systems and continuous improvement principles, including their application to QC laboratory operations and regulated environments

You have a solid understanding of drug development processes from discovery through CMC development, with the ability to translate business and regulatory requirements into practical, compliant solutions

You have experience supporting, configuring, or owning QC laboratory electronic systems (e.g., LIMS, LES, CDS) in a GMP-regulated environment, including system lifecycle management and change control

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