OmniaBio Inc. is a technology-driven, global CDMO specializing in cell and gene therapies, with a mission to transform biomanufacturing with AI and automation. Located at McMaster Innovation Park in Hamilton, Ontario, OmniaBio leverages over a decade of expertise in regenerative medicine and advanced therapies developed in partnership with CCRM. Committed to digital transformation, OmniaBio integrates automation, robotics, and artificial intelligence into its operations to drive efficiency, enhance quality, and increase throughput.

This cutting-edge approach supports end-to-end CDMO services—from development through GMP manufacturing and scale-up—helping clients accelerate the path to market for transformative treatments. With a strategic vision to meet the surging global demand, OmniaBio aims to enable broad access to cutting‑edge therapies worldwide. As the Associate I, Quality Control at OmniaBio, you are a motivated individual with a keen interest in the field of quality control (QC) for Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products, driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine.

The Associate I, Quality Control, will be required to work across the entire range of activities, including but not limited to, testing, sample management, equipment qualification, method development and optimization, and data review. You will demonstrate flexibility within the Quality team and larger organization, managing work priorities, as required. You will ensure the high-quality delivery of contract services.

Delivers quality control-related services, including sample management, testing, method development, optimization, qualification and validation, stability program, data review and equipment management. Maintains the materials specification program, as directed. Releases materials, as directed.

Adheres to the QC documentation quality management system program, including SOPs, logbook and associated forms.



Performs material testing in compliance with approved and current specifications, including but not limited to, incoming materials, in-process materials, drug substance materials, drug product materials, environmental monitoring samples, and stability samples, as required. Collaborates with the Facilities and Engineering team to ensure that facilities are available for production, including but not limited to, room readiness and environmental monitoring data.

Reviews and assesses deviations, corrective and preventative actions, change controls, etc. Continuously grows and adapts in a fast-moving field to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields. Engages and supports the OmniaBio Operating Model continuous improvement philosophy. 1-2 years of experience in cell therapy/viral quality control department supporting GMP production, or similar within the pharmaceutical, medical technologies, biologics or similar industries. ~ Experience working for a CDMO, a third-party testing facility or a biotechnology company performing similar activities. ~ Excellent understanding of Health Canada/US Food and Drug Administration GMP regulations and quality assurance principles.

Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, ISO, or medical device development.

Experience establishing customer-facing organizations and service models. Demonstrated initiative and the ability to deliver high-quality outcomes. An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.

OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position.

📌 Quality Control Associate Full Time (Canada)
🏢 OmniaBio
📍 Canada