GMP QA Associate I — Cell Therapy Manufacturing

OmniaBio; Hamilton; On-site; CAD 55,000 - 75,000; Full time

Job summary

OmniaBio Inc. in Hamilton, Ontario, is seeking an Associate I, QA to support GMP manufacturing of cell and gene therapy products.

The role spans quality systems, manufacturing quality, and outsourced activities, with emphasis on ensuring high-quality contract services and regulatory readiness. The successful candidate will contribute to master batch records, training, deviations, CAPAs, and change controls while collaborating with Manufacturing, MSAT, QC, and QA leadership to embed GMP across

Qualifications

• High school diploma with additional college courses in the field of science or engineering.
• 1-2 years of experience in cell therapy/viral quality department supporting GMP production, or similar within related industries.
• Understanding of Health Canada/U.S. FDA GMP regulations and QA principles.

Responsibilities

• Delivers quality-related services including product release to various clients.
• Prepares master batch documentation and specification systems.
• Prepares metrics and trend data for quality processes.
• Provides on-the-floor support for manufacturing teams to ensure GMP compliance.
• Leads or participates in internal audits and regulatory inspections.
• Manages documentation and training programs across the organization.
• Supports vendor management and continuous improvement of quality systems.

Skills

Attention to detail

Quality Assurance

Regulatory compliance

GMP knowledge

Education

High school diploma with college courses in science or engineering

Tools

MasterControl

Job description

OmniaBio Inc. in Hamilton, Ontario, is seeking an Associate I, QA to support GMP manufacturing of cell and gene therapy products.

The role spans quality systems, manufacturing quality, and outsourced activities, with emphasis on ensuring high-quality contract services and regulatory readiness. The successful candidate will contribute to master batch records, training, deviations, CAPAs, and change controls while collaborating with Manufacturing, MSAT, QC, and QA leadership to embed GMP across