- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, ... Lead role is an exempt level position with responsibilities for supporting the quality systems processes within a cell therapy manufacturing facility to support both… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role OverviewThe QA Shop Floor ... Specialist is an exempt level position responsible for the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigation Lead is an ... Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events that occur… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CAR-T drug product for human use. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, ... activities for designated team members.Support Investigations team by providing quality and compliance input for continuous improvement; and remediations.Lead … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the ... of the equipment and takes actions to optimize the output, reliability, quality , performance. He/she makes proposals for Continuous improvement and gets to work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking QA Validation Specialist I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Validation Specialist role is ... an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy manufacturing processes. This role ... analysis, impact assessment, and CAPA/EC determination.Work cross functionally with SME's and Quality to ensure robustness of investigations, as well as accuracy and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sheet development, and negotiate contracts.Lead cross-functional teams and collaborate with Quality , Legal, CMC, MSAT, Manufacturing, Supply Chain, and Regulatory to ... between internal teams across regions (US and Europe), TechOps, and Quality to coordinate tasks and deliverables.Assist in developing corporate policies and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, ... Practices (GDP).Perform tasks on time in a manner consistent with quality systems and cGMP requirements.Work in a team based, cross-functional environment… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with Manufacturing, Warehouse, ... Engineering, and Quality , and work as part of a cross-functional team...supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility emergency response plans and other required safety programs. Supports Quality driven initiatives related to facilities work such as change control, ... concerns.Ability to interact with all levels within the organization. (Operations, Quality , HSE, Supply Chain, Warehouse, Training, QC, EM, Operations Technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …not limited to Operations, MSAT, Facilities, C&Q, Project Management, and Quality .Work closely with Sr. Manager, Strategic Initiatives to support various strategic ... EMPQ, APS, PPQ, preferred.Experience with change management/change control and quality systems.Experience with FMEA and risk assessment tools.Experience with user… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …size.Responsible for multiple work centers within the facility to ensure high quality and compliant product supply and oversee production metrics; these metrics will ... range from employee engagement, safe behavior, quality performance (right first time), schedule adherence, and productivity improvements.Support manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …individual will partner with Plant Leadership and various Technical Operation and Quality functions in support of personalized cell therapy production through safe ... project plans across functional teamsDefines the interdependent deliverables and ensures that quality , risk, cost, time are managed within the overall approved plan… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …various Technical Operations groups [e.g., Operations, MS&T, Supply Chain, etc.] and Quality functions to lead all planning and detailed scheduling activities for ... assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …training tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, ... Documentation Practices (GDP).Perform tasks on time in a manner consistent with quality systems, and cGMP, and Learning Management System (LMS) requirements.Work in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for site's Strategic Initiatives Team.Defines the interdependent deliverables and ensures that quality , risk, cost, time are managed within the overall approved plan ... application to drug product manufacturing required to deliver time, cost, quality , and risk management to teams.Experience with Healthy Authority requirements and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and root cause analyses on any supply disruptions or material quality related issues.Support Quality , Regulatory and Financial audits.Provide timely ... assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Training systemsKnowledge of LMS systemSupports the maintenance and reporting of quality training metricsJob duties performed routinely require exposure to and ... within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management systems.Knowledge of cGMP regulations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site Readiness of MES for FDA ... would provide reduction in COGs, and increase throughput, capacity, and quality compliance.Work cross-functionally across Technical Operations and interface with IT… more
