Associate Ii, Quality Assurance

4 months ago

Hamilton, Canada Omniabio Full time

**About OmniaBio**:
OmniaBio Inc. is a subsidiary of Toronto-based CCRM (ccrm.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.

**Position Summary**:
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; communicating to customers, leadership, personnel and management; and ensuring the high-quality delivery of contract services.

**Responsibilities**:

- 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.
- Maintains the master batch documentation and specification systems.
- Provides in-suite and on-the-floor support for OmniaBio’s manufacturing teams, ensuring compliance with a fast-to-patient mindset. Along with the Manufacturing and MSAT teams, co-creates solutions to remediate compliance and quality issues.
- Releases materials.
- Reviews completed batch records and associated records to ensure compliance to GMPs, works with Manufacturing and MSAT team colleagues to remedy non-compliance and adherence to Good Documentation Practices.
- Performs batch release, in collaboration with client, and ensures all batch documentation is complete and available for approval.
- Conducts internal audits and/or supplier audits, as required.
- Administers documentation and training programs to the organization.
- Participates in client audits and health authority audits, as required.
- Collaborates with Facilities/Engineering to ensure that facilities are available for production, including, but not limited to, room readiness, calibration and maintenance activities.
- Administers the vendor management program.
- Builds and manages quality systems, as required.
- Reviews and assesses deviations, corrective and preventive action, change controls, etc.
- 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.
- 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 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.
- Practical leadership experience.
- Strong understanding of cell manufacture processes and technologies.
- Excellent understanding of Health Canada/U.S. Food and Drug Administration 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 able 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

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