OmniaBio: Associate I Quality Assurance (MQA)

Hamilton, ON, Canada

Job Description

Posted Friday, August 7, 2026 at 4:00 AM

About OmniaBio:

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. OmniaBio 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, OmniaBio aims to enable broad access to cutting‑edge therapies worldwide. Visit to learn more.

Active Vacancy

Position Summary

As Associate I, Quality Assurance (QA),at OmniaBio, you are a motivated individual in the field of Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products whoisdriven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The QA teamis responsible forall aspectsof GMP for the organization and the AssociateI,QA,willbe requiredto work across the entire range of activities, including,



but not limited to,quality system management,manufacturing quality,andoutsourced activities.You will demonstrate flexibility within the QA teamand larger organization,navigatingwork priorities,as required.Youwill ensure the high‑quality delivery of contract services.

Responsibilities

Manufacturing Quality Assurance

- Delivers quality‑related services including product release, as contracted, to various cell and viral product‑centered clients.
- Prepares the master batch documentation and specification systems, as required.
- Prepares metrics and trend data.
- Provides in‑suite and on‑the‑floor support for OmniaBio’s manufacturing teams, ensuring compliance with a fast‑to‑patient mindset.
- Preparesthe release of packages for approval.
- Reviews completed batch records and associated records to ensure GMP compliance and collaborates with colleagues on the Manufacturing and the Manufacturing Science and Technology (MSAT) teams to remedynon‑compliance.
- Participates in internal audits, supplier audits, or regulatory inspections as required.
- Administers documentation and training programs to the organization.
- Supportsthe vendor management program.
- Supports quality systems, as required.
- Prepares and manages deviations, corrective and preventive action, change controls, etc.
- Collaborates with Manufacturing,



MSAT, Quality Control (QC) and QA leadership in the preparation of master batch record and specifications.
- Participates in internal, client and health authority audits, as required.
- Collaborates with Facilities/Engineering to ensure that facilities are available for production, including, but not limited to, room readiness, calibration and maintenance activities.
- Supports validation in the collaboration, review and approval of master qualification protocols, executed protocols, and summary reports.
- Ensures GMP is embedded in all manufacturing‑related tasks.
- Engages and supports the OmniaBio Operating Model continuous improvement philosophy.

ComplianceQuality Assurance

- Delivers quality‑related services to various cell and viral product‑centered clients.
- Prepares and issues GMP documentation, such as batch records and supporting documents, labels, logbooks, forms, etc. ensuring accuracy and compliance with GMP requirements.
- Prepares metrics and trend data.
- Leads or participates in internal audits, supplier audits, or regulatory inspections as required.
- Administers documentation and training programs to the organization.
- Administers documentation, including tasks in Master Control such as creating and verifying Info Card information and reviewing document format.
- Conducts content review and approval of controlled documents.
- Ensures proper retention and archival of documents as per internal procedures and regulatory requirements.
- Provides QA support for document lifecycle activities, including periodic review and obsolescence.
- Assists in the maintenance and cont

📌 OmniaBio: Associate I Quality Assurance (Canada)
🏢 OmniaBio
📍 Canada