Quality Control Coordinator

Position Summary:

As the Quality Control Coordinator at OmniaBio, you are a motivated individual in the field of Quality Control for Good Manufacturing Practices (GMP) manufacturing. The Quality Control (QC) team is responsible for all aspect of QC for the organization and the Quality Control Coordinator will be required to work across the entire range of activities, including but not limited to materials management, sample management, data review and compliance activities. You will demonstrate flexibility within the quality and larger organization, following the work priorities as required. You will provide support to ensure the department activities are completed on time and as assigned. You will ensure the high-quality delivery of contract services.

Responsibilities:

• Deliver quality control related services as contracted, to various cell and viral product centered clients.
• Comply with all standard operating procedures and work practices.
• Manage retain and reference standard program as directed.
• Maintain the sample management program, including sample identification, storage and retention.
• Maintain QC materials management program, including inventory management, ordering and receipt.
• Assist with QC doc control and compliance management.
• Assist with data review of QC test records and log books as required.
• Participate in internal audits and/or supplier audits as required.
• Participate in Client audits and Health Authority audits as required.
• Continuously grow and adapt in a fast-moving field to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.
• Engage and support the OmniaBio Operating Model (OBOM) CI philosophy.
• Adhere to the QC documentation (QMS) program, including SOPs, logbooks and associated forms.
• Work with QA, Production, SC and MSAT colleagues to remedy non-compliance and adherence to Good Documentation Practices.
• Support in coordinating the third-party testing by OmniaBio approved laboratories.

As required, any other related activities in the Quality Control Department.

Requirements:

• High school + additional science related program up to 1 year.
• Up to and including 1 year of practical and related experience and/or 6 months on-the-job training in pharmaceutical, medical technologies, biologics or similar industries.
• Flexible to work in the fast-paced working environment.

Desired Characteristics:

• Independent, detail-oriented, self-starter with the ability to multitask and succeed in a team environment.
• Demonstrated initiative and the ability to deliver high quality outcomes.