QA Laboratory Compliance Specialist III
The QA Laboratory Compliance Specialist III at Legend Biotech US is a pivotal role within the Quality team, based in Raritan, New Jersey. This position focuses on providing quality and compliance oversight for all functions of the Quality Control Laboratories responsible for testing advanced therapy products. The specialist will collaborate closely with various Quality Control departments, including QC Release, QC IPL, QC Micro, QC Lab Services, and QC Investigations, to ensure adherence to global standards and regulatory requirements.
Key responsibilities include working in close collaboration with QC functional areas to provide QA oversight, attending one-on-one meetings with QA supervisors, and training and coaching Level I/II QALC staff. The specialist will oversee QC laboratories to ensure quality, compliance, and adherence to global standards, support the supervisor in managing cross-functional projects with QC Functional Area Owners, and perform ad-hoc walk-throughs of QC labs to ensure GMP compliance. Additional duties involve performing formbook reviews, UARs, SOP reviews, quarterly trend reports, and spot checks, as well as collaborating with QA supervisors and QC Functional Areas to address trends identified during spot checks and walk-throughs.
The ideal candidate should possess a minimum of a Bachelor’s Degree in Science or a related technical discipline, with at least 2 years of relevant work experience. Experience in quality assurance within a regulated environment, particularly in the biotechnology or pharmaceutical industry, is preferred. Strong knowledge of Good Manufacturing Practices (GMP) and regulatory compliance is essential. The candidate should also demonstrate excellent communication skills, attention to detail, and the ability to work effectively in a collaborative team setting.
While specific compensation details are not provided, Legend Biotech US offers a comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development. Employees are encouraged to engage in continuous learning and growth within the company.
Legend Biotech US fosters a collaborative and innovative work environment, emphasizing the development of advanced cell therapies to treat life-threatening diseases. The company values diversity and inclusion, providing employees with opportunities to contribute to meaningful projects that impact patient care globally.