Associate II, Quality Assurance

Position SummaryAs 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.ResponsibilitiesDel iver s quality - related services including product release, as contracted, to various cell and viral product - centered clients.Collaborate s with the Manufacturing, Manufacturing Science and Technology (MSAT), and Quality Control (QC) teams in the preparation of master batch record and specifications.Maintain s the master batch documentation and specification systems.Provide s 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 team s, co - create s solutions to remediate compliance and quality issue s.Release s materials.Review s completed batch records and associated records to ensure compliance to GMPs, work s with Manufacturing and MSAT team colleagues to remedy non-compliance and adherence to Good Documentation Practices.Perform s batch release, in collaboration with client, and ensure s all batch documentation is complete and available for approval.Conduct s internal audits and/or supplier audits, as required.Administer s documentation and training programs to the organization.Participate s in client audits and health authority audits, as required.Collaborate s with Facilities / Engineering to ensure that facilities are available for production, including, but not limited to, room readiness, calibration and maintenance activities.Administer s the vendor management program.Build s and manage s quality systems, as required.Review s and assess es deviations, corrective and preventive action, change e control, etc.Liaise s with clients and third-party contract services to ensure quality support is provided when needed.Represent s OmniaBio and promote s its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues and customer visits.Continuously grow s and adapt s in a fast-moving field, keep ing yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.En sure s GMP is embedded in all manufacturing - related tasks.Engage s and support s the OmniaBio Operating Model continuous improvement philosophy.RequirementsBachelor’s degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry , etc.); master’s degree preferred.4-6 years of experience in cell therapy/viral quality department supporting GMP production, or similar within the pharmaceutical, medical technologies, biologics or similar industries.Experience working for a c ontract development and m anufacturing o rganization, a third-party testing facility or a biotechnology company performing similar activities.Practical leadership experience.Strong understanding of cell manufacture processes and technologies.Excellent u nderstanding of Health Canada/U . S . Food and Drug Administration GMP regulations and QA principles.Desired CharacteristicsSound 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.Equal Employment Opportunity & EligibilityApplicants must be legally eligible to work in Canada. OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, ensuring 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. #J-18808-Ljbffr