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Added 1 min ago
PG
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OmniaBio

Associate II, Quality Control

Hamilton, ON, Canada

$65,000 to $75,000 CAD / year · Full-time

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Job details

Pay: $65,000 to $75,000 CAD / year
Job type: Full-time
Apply by: Dec 4, 2026
Posting language: English
Posted: Nov 4, 2026

Original job description

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 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. 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 www.omniabio.com to learn more.

Position Summary:

As the Associate II, Quality Control, at OmniaBio, you are an experienced individual 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 II, 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 provide technical expertise and will be an active contributor in client audits and communication to customers and management. You will ensure the high-quality delivery of contract services.

Responsibilities:

•Delivers quality control-related services including sample management, testing, method development, optimization, qualification and validation, stability program, data review and equipment management.

•Collaborates with the Production, Manufacturing Science and Technology (MSAT), and Quality Assurance (QA) teams in the preparation of master batch record, sampling plans, and specifications.

•Maintains the materials specification program.

•Releases materials.

•Manages the retain and references standard program.

•Manages the QC documentation quality management system program, including standard operating procedures, logbook and associated forms.

•Manages the OOT/OOS and retest program, ensuring strict adherence to regulation.

•Maintains the sample management program, including sample identification, storage and retention.

•Reviews completed records to ensure GMP compliance and works with production and MSAT colleagues to remedy non-compliance and adherence to Good Documentation Practices.

•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.

•Participates in internal audits and/or supplier audits.

•Administers the documentation and training programs to the QC function.

•Participates in client audits and health authority audits.

•Collaborates with the Facilities and Engineering team to ensure facilities are available for production, including but not limited to, room readiness and environmental monitoring data.

•Builds and manages QC systems.

•Reviews and assesses deviations, corrective and preventative actions, change controls, etc.

•Liaises with clients and third-party contract services to ensure quality control activities are delivered at the required quality.

•Represents OmniaBio and promotes its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, customer visits and other venues.

•Continuously grows and adapts to keep OmniaBio at the forefront of the dynamic cell and gene therapy and regenerative medicine fields.

Ensures GMP is embedded in all manufacturing-related tasks.

Engages and supports the OmniaBio Operating Model continuous improvement philosophy.

Requirements:

•Bachelor’s degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry etc.); master’s degree preferred.

•4-6 years of experience in a cell therapy/viral quality control department supporting GMP production, or similar, within pharmaceutical, medical technologies, biologics, or similar industries.

•Experience working for a CDMO, a third-party testing facility or a biotechnology company performing similar activities.

•Strong understanding of cell manufacture processes and technologies.

Excellent understanding of Health Canada/US Food and Drug Administration (FDA) GMP regulations and QA principles.

Desired Characteristics:

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

•Independent, detail-oriented self-starter with excellent analytical skills and able to multitask and succeed in a team environment.

•Experience establishing customer-facing organizations and service models.

•Demonstrated initiative and ability to deliver high-quality outcomes.

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More about this job

Responsibilities

Delivers GMP quality control services across sample management, testing, method development and validation, stability, equipment management, and data review. Maintains QC systems and documentation, supports audits and investigations, collaborates with manufacturing and quality teams, and ensures compliant, high-quality services for clients.

Requirements

Requires a bachelor’s degree in a relevant science or engineering field and 4–6 years of experience in GMP quality control supporting cell therapy, viral products, or a related industry; a master’s degree is preferred. Candidates should understand cell manufacturing processes and applicable GMP regulations, with strong analytical, organizational, and teamwork skills.

Skills

GMP Quality Control
Cell And Gene Therapy
Sample Management
Material Testing
Method Development And Validation
Data Review
Equipment Qualification
Stability Programs
GMP Documentation
Out-Of-Specification Investigations
Regulatory Compliance
Audit Participation
Deviation And CAPA Management
Change Control
Environmental Monitoring
Cross-Functional Collaboration

Visa sponsorship

Not detected in the job text

Keywords

Good Manufacturing Practices
Quality Control
Cell And Gene Therapy
Regenerative Medicine
CDMO
GMP Manufacturing
Cell Therapy
Viral Vectors
Lentiviral Vectors
Sample Management
Material Specifications
Material Release
Method Development
Method Optimization
Qualification And Validation
Stability Program
Equipment Management
Environmental Monitoring
Good Documentation Practices
Out-Of-Specification
Out-Of-Trend
Deviation Management
Corrective And Preventive Actions
Change Control
Health Canada
FDA
ISO
Client Audits
Quality Management System
Continuous Improvement

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