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The Operations Support Specialist supports process operations in a cGMP environment by performing floor service tasks, maintaining compliance with safety and quality standards, and collaborating with cross-functional teams to improve manufacturing processes.
The CQV Specialist I will oversee commissioning, qualification, and validation activities in a cGMP compliant cell therapy manufacturing plant, ensuring safe operations and adherence to regulations. This role includes managing CQV projects, executing protocols, and collaborating with cross-functional teams for effective production and testing.
The Sr. QC Analyst is responsible for performing QC testing of CAR-T cell therapy products under GMP conditions. This includes testing raw materials and final products, complying with regulations, reviewing laboratory data, and maintaining documentation using electronic systems. The position requires collaboration with multiple teams and shifts during evenings and weekends.
The QC Analyst at Legend Biotech is responsible for performing QC testing related to the manufacturing of cell therapy products in a controlled GMP environment. They work with Process Development, Quality, and Operations teams to transfer processes and conduct analytical testing of samples. The role also involves creating and approving QC documents and ensuring compliance with safety and quality requirements.
The Quality Compliance Lead is responsible for ensuring regulatory compliance for the production of autologous CAR-T products. Responsibilities include managing internal audit processes, coordinating health authority audits, resolving audit observations, developing training sessions, conducting data analysis, and maintaining a state of inspection readiness in a cGMP cleanroom environment.
The QC Investigations Specialist will lead investigations related to laboratory deviations and corrective actions in a GMP environment. Responsibilities include interviewing personnel, reviewing CAR-T manufacturing nonconformance investigations, collaborating on improvement initiatives, monitoring metrics, and ensuring compliance with quality and safety standards.
QA Investigations Lead responsible for quality oversight in producing personalized cell therapy, ensuring compliance, managing investigations, and tracking metrics in a sterile GMP environment. Collaborates with teams, reviews procedures, and supports regulatory inspections. Requires Bachelor's Degree and 4 years of relevant experience in aseptic manufacturing facility.
The QA Document Control Specialist is responsible for supporting the document management process within a cell therapy manufacturing facility to ensure compliance and meet clinical and commercial requirements. This role involves issuing batch-related documentation, reconciling documents, creating logbooks, storing and archiving documents, and driving continuous improvement.
The Senior Scientist will lead research in cell-based therapies, focusing on CAR-T cell engineering, lentivirus vector design, and optimizing cellular immunoassays. Responsibilities include designing experiments, collaborating with cross-functional teams, and advancing preclinical findings into clinical applications while meeting project timelines.
The Project Engineer (Contractor) will support the execution of engineering and facility projects, including project initiation, budgeting, scheduling, monitoring, and closure. Responsibilities include coordinating with various departments, maintaining compliance, managing project updates, and ensuring project completion according to safety and regulatory standards.
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