Company Information
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking QA Shop Floor Supervisor as part of the Quality team based in Raritan, NJ.
Role Overview
The QA Shop Floor Supervisor is an exempt level position with responsibilities for providing quality oversight over the production of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes supervision of QA shop floor personnel as well as working with manufacturing to troubleshoot issues.
Key Responsibilities
- Read, interpret and revise documents such as SOPs, work instructions.
- Develop positive relationship with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and peers.
- Harmonize with Environmental, Health, and Safety personnel, Product Development, and Quality/Manufacturing personnel.
- Independently makes appropriate and compliant GMP decisions.
- Independently resolves problems through the use of quality systems.
- Develop improvement ideas and independently implement associated solutions.
- Support QPIP team development.
- Must be able to be Aseptic Gown Qualified
- Possess the ability to positively influence peers, key stakeholders and management.
- Generates shift schedules, to ensure efficient coverage for all operational needs.
- Maintain individual training completion in a compliant state.
- Supports the completion of corrective and preventive actions, as necessary.
- Supports internal/external audits.
- Supports Quality risk assessment teams.
- Review/approve documents as a Quality on the Floor Subject Matter Expert (SME).
- Remain current in skills and industry trends.
Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
Legend Biotech maintains a drug-free workplace.