MEDICAL OFFICE ASSOCIATE

3 weeks ago

Toronto ON, Canada OmniaBio Full time

Department: Quality
ca), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio’s facility will be Canada’s first commercial-scale contract development and manufacturing organization (CDMO) dedicated to cell and gene therapies and is expected to be the largest facility of its kind in Canada.

Based at McMaster Innovation Park in Hamilton, Ontario, OmniaBio will anchor a biomanufacturing centre of excellence and open in three phases between 2024 and 2026. Benefitting from CCRM’s existing expertise and business practices, OmniaBio currently has established process and analytical development teams and contract manufacturing capabilities. The vision is to provide focused support for clients with late clinical-stage manufacturing and commercial supply needs, in addition to early-stage development and first in-human clinical trial material services. As the Associate II, Quality Assurance (QA), at OmniaBio, you are an experienced individual in the field of Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products who is driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The QA team is responsible for all aspects of GMP for the organization and the Associate II, QA, will be required to work across the entire range of activities, including, but not limited to, quality system management, manufacturing quality, and outsourced activities. You will demonstrate flexibility within the QA team and larger organization, navigating work priorities, as required. You will provide technical expertise and will be responsible for client audits; and ensuring the high-quality delivery of contract services.

Delivers quality-related services including product release, as contracted, to various cell and viral product-centered clients.
Collaborates with the Manufacturing, Manufacturing Science and Technology (MSAT), and Quality Control (QC) teams in the preparation of master batch record and specifications.
Along with the Manufacturing and MSAT teams, co-creates solutions to remediate compliance and quality issues.
Administers documentation and training programs to the organization.
Collaborates with Facilities/Engineering to ensure that facilities are available for production, including, but not limited to, room readiness, calibration and maintenance activities.
Builds and manages quality systems, as required.
Liaises with clients and third-party contract services to ensure quality support is provided when needed.
Represents OmniaBio and promotes its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues and customer visits.
Continuously grows and adapts in a fast-moving field, keeping yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.
Bachelor’s degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry, etc.); 4-6 years of experience in cell therapy/viral quality department supporting GMP production, or similar within the pharmaceutical, medical technologies, biologics or similar industries.
~ Experience working for a contract development and manufacturing organization, a third-party testing facility or a biotechnology company performing similar activities.
~ Food and Drug Administration GMP regulations and QA principles.


Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, ISO or medical device development.
Demonstrated initiative and able to deliver high-quality outcomes.

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.

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