- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy ... management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production… more
- Eisai, Inc (Chicago, IL)
- …technical oversight and troubleshooting for eCTD submissions and related systems .Operational ExcellenceEnsure consistent application of GSM global procedures and ... knowledge of global regulatory submission standards, publishing software, software validation concepts, and regulatory publishing best practicesProficiency in eCTD… more
- Genmab (NJ)
- …according to applicable SOPsGive input to eCRF setup, edit checks, validation plan, protocol deviations classifications, DSUR, IB updates, tables, figures, and ... listings etc.Review assay validation reports, as applicablePerform exploratory analysis, ad hoc analyses,...stratification plansPerform UAT of Randomization part of the IRT system as applicableEnsure procedures for blinding are in place… more
- Insmed Incorporated (NJ)
- …financial system . You'll also: Assist with supplier data clean-up, validation , and maintenance to ensure accuracy across procurement and accounts payable ... Procure-to-Pay (P2P) transformation by assisting with data integrity, process analysis, and system readiness efforts as we prepare for the implementation of our new… more
- Takeda Pharmaceutical (Los Angeles, CA)
- …OOS/OOT rates, and turnaround time. Collaborate with QC, IT, Digital, Validation , Manufacturing, and Quality Systems on LIMS enhancements, integrations, ... LabWare LIMS, including configuration, master data management, workflow design, and system optimization. Experience supporting change control, validation , and… more
- Merck & Co. (Rahway, NJ)
- …Minimum Requirement: BA/BS in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus 15 years of ... Skills: 10+ years of experience in process improvement, Quality management system , operational excellence, and product development Has broad knowledge of combination… more
- Merck & Co. (Rahway, NJ)
- …qualification activities for shock and vibration as well as thermal protection system testing and qualification and leading execution of qualification of complex ... systems .-The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and 3rd party logistics… more
- Christus Health (Odem, TX)
- …surgical suites A teaching facility in affiliation with the Texas A&M University System Health and Science Center College of Medicine Accredited Chest Pain Center ... through successful completion of the designated organizational entry competency validation and a Perioperative Department-specific competency validation .… more
- Christus Health (Sinton, TX)
- …surgical suites A teaching facility in affiliation with the Texas A&M University System Health and Science Center College of Medicine Accredited Chest Pain Center ... through successful completion of the designated organizational entry competency validation and a Perioperative Department-specific competency validation .… more
- Christus Health (Odem, TX)
- …suites - A teaching facility in affiliation with the Texas A&M University System Health and Science Center College of Medicine - Accredited Chest Pain Center ... through successful completion of the designated organizational entry competency validation and a Perioperative Department-specific competency validation . -… more
