Cell And Gene Therapy Qc Specialist

Support OmniaBio’s cell and gene therapy programs with quality control testing, method optimization, and regulatory-compliant documentation.As an experienced Associate II, Quality Control, you will provide technical expertise across GMP manufacturing activities. Your work will include OOT/OOS management, deviations, change controls, sample programs, and data review. You will collaborate with Production, MSAT, QA, Facilities, Engineering, clients, and third-party services to maintain quality delivery.Key Responsibilities:
Manage OOT, OOS, retest, and sample management programsMaintain materials specifications and release materialsAdminister QC documentation, training, procedures, and formsAssess deviations, corrective actions, and change controlsLiaise with clients and third-party contract servicesRequirements:
Science bachelor’s degree in biotechnology, chemistry, biology, or related disciplineFour to six years in GMP quality control or similarExperience performing comparable activities for a CDMO or biotechnology companyKnowledge of cell manufacturing processes and technologiesUnderstanding of GMP regulations and quality assurance principlesUse your QC systems, documentation, and compliance experience to support reliable cell and gene therapy services at OmniaBio.
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