2.0 - 6.0 years

0 Lacs

maharashtra

On-site

As a Quality Control Testing Technician in a Cell Therapy Lab, your primary responsibility is to ensure the quality and safety of cell therapy products through rigorous testing and analysis. You will work in a highly regulated environment, adhering to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) to support the development and production of cell-based therapies. This role requires a strong attention to detail, analytical skills, and the ability to work collaboratively with cross-functional teams. You will execute a variety of tests to assess the quality, purity, and potency of cell therapy products, including but not limited to viability assays, sterility testing, endotoxin testing, and identity testing. Operate and maintain specialized laboratory equipment and instruments used in cell therapy testing, such as flow cytometers, PCR machines, and automated cell counters. Maintain accurate and detailed records of all testing activities, ensuring compliance with regulatory requirements. Document deviations, investigations, and corrective actions as necessary. You are expected to stay current with industry regulations and standards related to cell therapy and ensure all testing activities align with applicable GMP, GLP, and other regulatory requirements. Participate in the validation and optimization of testing methods, ensuring that methods are robust, accurate, and reproducible. Work closely with Research and Development teams to transfer validated methods into routine quality control testing and collaborate with Production teams to troubleshoot and resolve any issues related to product quality. Conduct environmental monitoring to ensure the cleanliness and sterility of the laboratory environment. Analyze test results and prepare detailed reports for review by senior management. Communicate any deviations or trends that may impact product quality. Participate in continuous improvement initiatives to enhance laboratory processes and procedures, providing input on improving efficiency and reducing testing turnaround times. Train and mentor junior staff members on laboratory techniques, safety protocols, and quality control procedures. Qualifications required for this role include a postgraduate or masters degree in Life Sciences/Biochemistry/Microbiology. Previous experience in a quality control or analytical testing role within the biopharmaceutical or cell therapy industry will be of added value but not compulsory. A strong understanding of GMP, GLP, and other regulatory requirements, excellent communication and teamwork skills, attention to detail, and a commitment to quality are essential for this position. This job description is a general outline of the responsibilities and qualifications typically associated with the position of a Quality Control Testing Technician in a Cell Therapy Lab. Specific duties and qualifications may vary depending on the organization and the stage of development and production of cell therapy products.,

Posted 6 days ago

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