OmniaBio: Quality Assurance Associate II

Omnia Bio:
Quality Assurance Associate II

Hamilton, ON, Canada

Posted Thursday, February 12, 2026 at 5:00 AM

About Omnia Bio:

Omnia Bio 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, Omnia Bio leverages over a decade of expertise in regenerative medicine and advanced therapies developed in partnership with CCRM. Committed to digital transformation, Omnia Bio integrates automation, robotics, and artificial intelligence into its operations to drive efficiency, enhance quality, and increase throughput.

This innovative 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. Omnia Bio focuses on immune cell-based therapies, induced pluripotent stem cell therapies, and lentiviral vectors, positioning itself as a leader in advancing and maturing cell and gene therapy manufacturing. With a strategic vision to meet the surging global demand, Omnia Bio aims to enable broad access to cutting‑edge therapies worldwide.  

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Active Vacancy

Position Summary:

As the A ssociate II , Quality Assurance (QA) , at Omnia Bio, you are an experienced individual in the field of G ood M anufacturing P ractices (GMP) manufacturing of cell and gene therapy products who is driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The QA team is responsible for all aspect s of GMP for the organization and the Associate II , QA , will be required to work across the entire range of activities, including , but not limited to , quality system management , manufacturing quality , and outsourced activities.

You will demonstrate flexibility within the QA team and larger organization, navigating work priorities , as required. You will provide technical expertise and will be responsible for client audits ; communica ting to customers, leadership, personnel and management ; and ensuring the high-quality delivery of contract services .

Responsibilities:

Del iver s quality - related services including product release, as contracted, to various cell and viral product - centered clients.

Collaborate s with the Manufacturing , Manufacturing Science and Technology (MSAT) , and Q uality C ontrol (QC) teams in the preparation of master batch record and specifications.

Maintain s the master batch documentation and specification systems.

Provide s in-suite and on - the - floor support for Omnia Bio’s manufacturing teams, ensuring complian ce with a fast - to - patient mindset . Along with the Manufacturing and MSAT team s, co - create s solutions to remediate compliance and quality issue s .

Release s materials .

Review s completed batch records and associated records to ensure compliance to GMPs, work s with Manufacturing and MSAT team colleagues to remedy non-compliance and adherence to Good Documentation Practices.

Perform s batch release , in collaboration with client, and ensure s all batch documentation is complete and available for approval.

Conduct s internal audits and/or supplier audits , as required .

Administer s documentation and training programs to the organization.

Participate s in c lient audits and h ealth a uthority audits , as required .

Collaborate s with Facilities /Engineering to ensure that facilities are available for production, including , but not limited to , room readiness, calib ration and maintenance activities .

Build s and manage s quality systems , as required .

Review s and assess es deviations, corrective and preventive action , c hang e c ontrols, etc.

Liaise s with clients and third-party contract services to ensure quality support is provided when needed.

Represent s Omnia Bio and promote s its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues and customer visits.

Continuously grow s and adapt s in a fast-moving field , keep ing yourself and the organization at the forefront of the cell and gene therapy and…