Quality assurance inspector Jobs in Hamilton, ON

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 :

Desired Characteristics :

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