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Position Summary:

As the Associate I, Quality Control at OmniaBio, you are a motivated individual with a keen interest in the field of quality control (QC) for Good Manufacturing Practices (GMP) manufacturing of cell and gene therapy products, driven by the opportunity to enable clinical translation of cell therapy and regenerative medicine. The Associate I, Quality Control, will be required to work across the entire range of activities, including but not limited to, testing, sample management, equipment qualification, method development and optimization, and data review. You will demonstrate flexibility within the Quality team and larger organization, managing work priorities, as required. You will ensure the high-quality delivery of contract services.

Responsibilities:

• Delivers quality control-related services, including sample management, testing, method development, optimization, qualification and validation, stability program, data review and equipment management.
• Complies with all standard operating procedures (SOPs) and work practices.
• Maintains the materials specification program, as directed.
• Releases materials, as directed.
• Manages the retain and reference standard program, as directed.
• Adheres to the QC documentation quality management system program, including SOPs, logbook and associated forms.
• Maintains the sample management program, including sample identification, storage and retention.
• Performs material testing in compliance with approved and current specifications, including but not limited to, incoming materials, in-process materials, drug substance materials, drug product materials, environmental monitoring samples, and stability samples, as required.
• Participates in internal audits and/or supplier audits, as required.
• Participates in client audits and health authority audits, as required.
• Collaborates with the Facilities and Engineering team to ensure that facilities are available for production, including but not limited to, room readiness and environmental monitoring data.
• Reviews and assesses deviations, corrective and preventative actions, change controls, etc.
• Continuously grows and adapts in a fast-moving field to keep 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:

• High school diploma, college diploma preferred.
• 1-2 years of experience in cell therapy/viral quality control department supporting GMP production, or similar within the pharmaceutical, medical technologies, biologics or similar industries.
• Experience working for a CDMO, a third-party testing facility or a biotechnology company performing similar activities.
• Strong understanding of cell manufacture processes and technologies.
• Excellent understanding of Health Canada/US Food and Drug Administration GMP regulations and quality assurance 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 the ability to deliver high-quality outcomes.