QA Investigations Lead II
The QA Investigations Lead II at Legend Biotech is a key member of the Quality team, responsible for overseeing quality investigations within the production of personalized cell therapy products in a sterile GMP environment. This role is based in Raritan, New Jersey, and reports to the QA Investigation Supervisor within the Raritan Investigation Excellence Team.
Key responsibilities include ensuring the timely completion of high-quality investigations with appropriate root causes, developing and implementing corrective and preventive actions (CAPAs), and escalating significant quality issues to management. The role also involves supporting regulatory inspections and audits, collaborating with site personnel to resolve manufacturing issues, and maintaining accurate records of manufacturing investigations, CAPAs, change controls, and complaints.
Candidates must possess a minimum of a Bachelor's Degree in Science, Engineering, or an equivalent technical discipline, along with 2-4 years of relevant work experience. Preferred experience includes working in an aseptic manufacturing facility, particularly in quality assurance, manufacturing compliance, clinical quality, or cell therapy. Essential skills include knowledge of cGMP and GDP regulations, attention to detail, strong organizational abilities, excellent communication skills, and the capacity to work both independently and collaboratively.
The position offers a base salary range of $61,454 to $80,656 annually, with potential for performance-based bonuses and equity. Benefits include medical, dental, and vision insurance, a 401(k) retirement plan with company match, paid parental leave, and a comprehensive paid time off policy encompassing vacation, personal, and sick days, as well as company holidays. Additional voluntary benefits are also available to support employees' well-being and professional growth.
Legend Biotech fosters a collaborative and innovative work environment, dedicated to treating and curing life-threatening diseases through advanced cell therapies. Employees are encouraged to contribute to cutting-edge therapeutics, with opportunities for professional development and growth within a global biotechnology company committed to excellence and continuous improvement.