Quality Control Associate I – Cell Therapy GMP Testing

OmniaBio Inc.; Hamilton; Hybrid; CAD 45,000 - 60,000; Full time

Job summary

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

The role spans testing, sample management, equipment qualification, method development, data review and document control within a fast-moving QC environment. You will contribute to ensuring high-quality contract services, maintain material specifications, and participate in internal, client, and health authority audits while collaborating with Facilities

Qualifications

• High school diploma, college diploma preferred.
• 1-2 years of experience in cell therapy/viral quality control supporting GMP production or similar.
• Experience with a CDMO, contract testing facility, or biotech company performing similar activities.
• Strong understanding of cell manufacture processes and technologies.
• Excellent understanding of Health Canada/US FDA GMP regulations and quality assurance principles.

Responsibilities

• Delivers QC-related services including sample management, testing, method development, optimization, qualification and validation, stability program, data review and equipment management.
• Complies with SOPs and work practices.
• Maintains the materials specification program.
• Releases materials.
• Manages the retain and reference standard program.
• Adheres to the QC documentation quality management system (SOPs, logbooks, forms).
• Maintains the sample management program including identification, storage and retention.
• Performs material testing per specifications (incoming, in-process, drug substances/products, environmental monitoring, stability).
• Participates in internal and supplier audits, and client/health authority audits as required.
• Collaborates with Facilities and Engineering to ensure room readiness and environmental monitoring data.
• Reviews and assesses deviations, CAPAs, change controls.
• Keeps pace in fast-moving cell/gene therapy field and ensures GMP embedding in manufacturing tasks.
• Supports OmniaBio Operating Model continuous improvement.

Skills

Cell therapy knowledge

GMP regulations understanding

Independent, detail-oriented

Auditing experience

Education

High school diploma

College diploma preferred

Job description

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

The role spans testing, sample management, equipment qualification, method development, data review and document control within a fast-moving QC environment. You will contribute to ensuring high-quality contract services, maintain material specifications, and participate in internal, client, and health authority audits while collaborating with Facilities