QC Analyst II
The QC Analyst II position at Legend Biotech involves performing quality control testing related to the manufacturing of cell therapy products for clinical trials and commercial operations within a controlled GMP environment. This role is integral to ensuring the safety and efficacy of the company's innovative therapies.
Key responsibilities include conducting analytical testing of raw materials, in-process materials, and final products; performing peer reviews and approvals of laboratory data; utilizing electronic systems for documentation; and creating, reviewing, and approving relevant quality control documents. The analyst will also collaborate with cross-functional teams, including Quality Assurance, Manufacturing Operations, and Analytical/Process Development, to maintain compliance with all applicable procedures, standards, and GMP regulations.
Candidates must possess a Bachelor's Degree in Science, Engineering, or an equivalent technical discipline, along with a minimum of one year of relevant work experience, preferably within the biological or pharmaceutical industry. Experience in a Quality Control setting and knowledge of cGMP regulations are preferred. Proficiency in aseptic techniques and familiarity with CAR-T QC test methods are advantageous. Strong written and oral communication skills are essential. The role requires flexibility to accommodate shift schedules, including routine weekend and evening work, as well as the ability to handle unplanned overtime with little to no prior notice.
Legend Biotech offers a comprehensive benefits package, including health insurance, retirement plans, and paid time off. Employees have access to professional development opportunities and are encouraged to engage in continuous learning to advance their careers within the company.
Joining Legend Biotech means becoming part of a global, commercial-stage biotechnology company dedicated to developing and manufacturing novel therapies. The company fosters a collaborative and innovative culture, providing employees with the opportunity to contribute to cutting-edge research and make a meaningful impact on patients' lives worldwide.