- Professional
- Optionales Büro in Hamilton
- 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 works with colleagues on the Manufacturing and the Manufacturing Science and Technology (MSAT) teams to remedy non-compliance.
- Participates in internal audits and/or supplier audits, 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 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.
- 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.
- 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.