Associate II, Quality Assurance

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 aspect(s) 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:

- Deliver quality-related services including product release, as contracted, to various cell and viral product-centered clients.

- Collaborate with the Manufacturing, Manufacturing Science and Technology (MSAT), and Quality Control (QC) teams in the preparation of master batch record and specifications.

- Maintain the master batch documentation and specification systems.

- Provide 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 team(s), co-create solutions to remediate compliance and quality issues.

- Releases materials.

- Reviews completed batch records and associated records to ensure compliance to GMPs, work 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 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.

- Represent OmniaBio and promote its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues and customer visits.

- Continuously grow and adapt in a fast-moving field, keeping yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.

- Ensure GMP is embedded in all manufacturing-related tasks.

- Engage and support 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/United States 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.

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