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Added 34 mins ago
SD
Caissier(ère), rémunéré(e) à l’heure – PHX temps partiel Quarts de travail flexibles Embauche feu vert
Shoppers Drug Mart
Sept-Îles, QC
- Part-time
Assurer un excellent service à la clientèle et une bonne tenue des caisses.
Added 34 mins ago
S
Seasonal Associate
sephora.com
Calgary, AB
- $17 to $20 CAD / hour
- Full-time
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Added 1 hour ago
GA
Sales Associate - West Edmonton Mall
Groupe APP - APP Group
AB · Edmonton, AB
- Part-time
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Added 1 hour ago
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Montreal, QC
- Full-time
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Added 2 hours ago
RB
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TD
Burnaby, BC
- Part-time
…with our customers by performing a broad range of customer service transactions and providing information and advice on services, products, and solutions to existing or prospective TD…
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Bilingual Sales Associate, Apartments.com/ Associé(e) aux ventes bilingue, Apartments.com - Montréal, Québec
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- Full-time
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Peterborough, ON
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- Full-time
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- Full-time
…to support clients with their everyday banking needs. As a Client Engagement Associate, you'll be the first line of support - answering questions, assisting with transactions, guiding…
Added 3 hours ago
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Personal Banking Associate - Robert-Bourassa Branch, Montreal
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Added 4 hours ago
T
Customer Experience Associate
TD
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- Part-time
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Added 4 hours ago
FR
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Added 4 hours ago
FR
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Vancouver, BC
- Full-time
The General Accounting Administrator, Investment Client Service supports the Investment Client Service (ICS) team with accounting, transaction administration, and non-resident tax matters.…

CCRM and OmniaBio

OmniaBio: Associate II Quality Control (13-month contract)

Hamilton, ON, Canada

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Job details

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.

Active Vacancy

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.

OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.

An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.

OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.

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More about this job

Responsibilities

The Associate II, Quality Control, will manage testing, sample management, equipment qualification, and method development to ensure GMP compliance. They will also collaborate with production and QA teams to review documentation, handle deviations, and participate in internal and client audits.

Requirements

Candidates must hold a bachelor's degree in a relevant science field, with a master's degree preferred. Applicants require 4-6 years of experience in a cell therapy or viral quality control department supporting GMP production.

Skills

Quality Control
GMP
Cell Therapy
Gene Therapy
Sample Management
Equipment Qualification
Method Development
Data Review
Regulatory Compliance
Documentation Management
Environmental Monitoring
Internal Audits
Supplier Audits
Biomanufacturing
Standard Operating Procedures
Corrective and Preventative Actions

Visa sponsorship

Not detected in the job text

Keywords

Quality Control
GMP
Cell Therapy
Gene Therapy
CDMO
Regenerative Medicine
Biomanufacturing
Health Canada
FDA
Quality Assurance
Sample Management
Method Validation
Stability Program
OOS
OOT
Standard Operating Procedures
Good Documentation Practices
Environmental Monitoring
Internal Audit
Supplier Audit
Corrective and Preventative Actions
Change Control
Biotechnology
Microbiology
Chemistry
Bioengineering
Chemical Engineering
Bioprocess
ISO
Medical Device

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