Quality Control Coordinator

Active Vacancy

About OmniaBio:

OmniaBio Inc. is a technology-driven, global CDMO specializing in cell and gene therapies, with a mission to transform biomanufacturing with AI and automation. Located at McMaster Innovation Park in Hamilton, Ontario, OmniaBio leverages over a decade of expertise in regenerative medicine and advanced therapies developed in partnership with CCRM. Committed to digital transformation, OmniaBio integrates automation, robotics, and artificial intelligence into its operations to drive efficiency, enhance quality, and increase throughput. This innovative approach supports end-to-end CDMO services - from development through GMP manufacturing and scale-up - helping clients accelerate the path to market for transformative treatments. OmniaBio focuses on immune cell-based therapies, induced pluripotent stem cell therapies, and lentiviral vectors, positioning itself as a leader in advancing and maturing cell and gene therapy manufacturing. With a strategic vision to meet the surging global demand, OmniaBio aims to enable broad access to cutting-edge therapies worldwide.

Visit www.omniabio.com to learn more.

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.
• Continuously grow and adapt in a fast-moving field to keep yourself and the organization at the forefront of the cell and gene therapy regenerative medicine fields.
• As required, any other related activities in the Quality Control Department.

Requirements:

• Highschool + 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.

OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.

An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.

OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.