- 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)
- …Preventative Actions (CAPA's) are developed and implemented.Escalation of events to management that potentially represent significant quality issues or issues ... seeking QA Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA...to discern the criticality of issues and communicate to management regarding complex issues.Ability to manage conflict and issues… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …discipline and its application to drug development required to deliver time, cost, quality , and risk management to teams.Demonstrated results in creating and ... OverviewThis position will be responsible for providing operational excellence project management support to the cGMP Clinical and Commercial Cell Therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operations management , tech transfer, process and equipment validation or quality management ; with a preference for Cell/Gene Therapy experienceMinimum of ... Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and performance management of staff in a growing operation in terms of volume/output… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …supports CAPAs (Corrective and Preventive Actions) and CCs (Change Controls) within quality management systems. You will also write SOPs (Standard Operating ... and work instructions that are part of the QMS ( Quality Management System).You combine the knowledge of...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)
- …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)
- …sheet development, and negotiate contracts.Lead cross-functional teams and collaborate with Quality , Legal, CMC, MSAT, Manufacturing, Supply Chain, and Regulatory to ... product competitiveness.Support CMO contract negotiations in conjunction with alliance management .Ensure target inventory levels are maintained and reported monthly.Build… more
- Lundbeck (San Diego, CA)
- …manager, sales operations, account management is a plus. Previous sales management experience in hospital , IDN and/or other institutional settings Documented ... identify improvement and development opportunities of account managers through performance management process to include clear, timely, and actionable feedback on a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements and breakdowns.cGMP manufacturingMaintenance and facilities managementComputerized maintenance management systems (CMMS) Quality Management ... standards.Performs work review, approval and close out of work orders, including management of third-party vendor work, in accordance with established guidelines and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …its application to drug product manufacturing required to deliver time, cost, quality , and risk management to teams.Experience with Healthy Authority ... implementation in cGMP production environment. The individual will be responsible for management and delivery of the integrated project and program plans, ensuring… 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)
- …specific and real-time floor service tasks (ie, kitting and kit cleaning, inventory management and data entry, sample management and data entry, aseptic behavior ... tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with Manufacturing, Warehouse,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …stakeholders including but not limited to Operations, MSAT, Facilities, C&Q, Project Management , and Quality .Work closely with Sr. Manager, Strategic Initiatives ... but not limited to IQ/OQ/PQ, EMPQ, APS, PPQ, preferred.Experience with change management /change control and quality systems.Experience with FMEA and risk… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Documentation Practices (GDP).Perform tasks on time in a manner consistent with quality systems, and cGMP, and Learning Management System (LMS) requirements.Work ... training tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or learning management systems.Knowledge of cGMP ... This individual will partner with Training team members in collaboration with management in Operations to support personalized cell therapy production through safe… 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)
- …drives and manages an effective, holistic continuous improvement, problem solving and management program to improve process execution and system utilization of the ... and to avoid duplication of efforts across sites.Apply and teach change management methodology in all aspects of the plant operational excellence effortsIdentify,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to manufacturing equipment projects, cost-improvement initiatives, asset management , reliability, and business operations.Support facility project initiatives ... with all company and/or site policies and proceduresSupport maintenance driven quality events including but not limited to Deviations/Investigations, Out of… 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 ... ability to follow procedures.Knowledge of supply chain principles (materials management , distribution, import/export, transportation, etc.), pharmaceutical operations, and industry… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …as supporting Procurement execution activities, cost analysis, inventory and vendor management - in accordance with company policies and site-specific procedures.The ... and root cause analyses on any supply disruptions or material quality related issues.Support Quality , Regulatory and Financial audits.Provide timely… more
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