Associate I, Quality Assurance

Position Summary:

As Associate I, Quality Assurance (QA), at OmniaBio, you are a motivated 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 I, 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 ensure the high-quality delivery of contract services.

Responsibilities:

Manufacturing Quality Assurance:

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

• Prepares the master batch documentation and specification systems, as required.

• Prepares metrics and trend data.

• Provides in-suite and on-the-floor support for OmniaBio's manufacturing teams, ensuring compliance with a fast-to-patient mindset.

• Prepares the release of packages for approval.

• Reviews completed batch records and associated records to ensure GMP compliance and collaborates with colleagues on the Manufacturing and the Manufacturing Science and Technology (MSAT) teams to remedy non-compliance.

• Participates in internal audits, supplier audits, or regulatory inspections as required.

• Administers documentation and training programs to the organization.

• Supports the vendor management program.

• Supports quality systems, as required.

• Prepares and manages deviations, corrective and preventive action, change controls, etc.

• Collaborates with Manufacturing, MSAT, Quality Control (QC) and QA leadership in the preparation of master batch record and specifications.

• Participates in internal, client 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.

• Supports validation in the collaboration, review and approval of master qualification protocols, executed protocols, and summary reports.

• Ensures GMP is embedded in all manufacturing-related tasks.

• Engages and supports the OmniaBio Operating Model continuous improvement philosophy.

Compliance Quality Assurance:

• Delivers quality-related services to various cell and viral product-centered clients.

• Prepares and issues GMP documentation, such as batch records and supporting documents, labels, logbooks, forms, etc. ensuring accuracy and compliance with GMP requirements.

• Prepares metrics and trend data.

• Leads or participates in internal audits, supplier audits, or regulatory inspections as required.

• Administers documentation and training programs to the organization.

• Administers documentation, including tasks in MasterControl such as creating and verifying InfoCard information and reviewing document format.

• Conducts content review and approval of controlled documents.

• Ensures proper retention and archival of documents as per internal procedures and regulatory requirements.

• Provides QA support for document lifecycle activities, including periodic review and obsolescence.

• Assists in the maintenance and continuous improvement of document control processes and training systems.

• Develop and/or support development, administer and/or maintain training programs and associated material/documentation.

• Monitor training status across the organization, ensuring alignment with quality and compliance standards.

• Supports quality systems, as required.

• Prepares and manages deviations, corrective and preventive action, change controls, etc.

• Communicates effectively with cross-functional teams to ensure timely resolution of documentation and training-related issues.

• Engages and supports the OmniaBio Operating Model continuous improvement philosophy.

Requirements:

• High school diploma with additional college courses in the field of science or engineering.

• 1-2 years of experience in cell therapy/viral quality department supporting GMP production, or similar within the pharmaceutical, medical technologies, biologics or similar industries.

• 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.