- Legend Biotech USA, Inc. (Raritan, NJ)
- …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, NJ. Role ... OverviewThe Quality Systems Lead role is an exempt level position with...assurance, manufacturing compliance, clinical quality, or cell therapy.GxP Quality System knowledge, including relevant regulations and guidances (eg 21… more
- Merck & Co. (Rahway, NJ)
- …Documentation, Testing, Implementation, Deployment and Hypercare phases.Facilitate and oversee the System Support Model for systems within remit including: ... Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min....liaison between the Global Labeling Business Users of the Systems and the associated IT Partners for defining Business… more
- Merck & Co. (Rahway, NJ)
- …techniquesDeveloping and implementing data analyses, data collection systems and other strategies that-optimize-statistical efficiency and quality.Develop ... improve performance.Apply technical skills and ingenuity to correct equipment and system problems that result in downtime or consume excessive maintenance resources… more
- Merck & Co. (Durham, NC)
- …and when required calibration activities to ensure applicable equipment and systems are maintained in a compliant state.Maintains the integrity of equipment ... specification data within the computerized calibration and maintenance management system .Troubleshoots equipment and performs necessary repairs. Utilizes various instruments… more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… more
- Merck & Co. (Omaha, NE)
- …be responsible for installing, maintaining, troubleshooting, and repairing equipment, utility systems , and facility needed for the storage, packaging and shipping of ... troubleshooting and maintaining equipment, performing root cause analysis on system failures and substandard equipment performance, using standard problem-solving… more
- Merck & Co. (Rahway, NJ)
- …review with clinical partners and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for all study product needs ... in critical non-pipeline activities. - Participate in Interactive Voice Response (IVR) System d evelopment and User Acceptance Testing (UAT) for assigned studies .… more
- Merck & Co. (Rahway, NJ)
- …release of drug product across assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for all product s used within ... the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, and best practices… more
- Merck & Co. (Rahway, NJ)
- …is preferred):BS/ BA degree in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering with a minimum of 20 ... development.MS/ MA degree in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering with a minimum of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols, reports).Review and approve periodic review documentation for qualified equipment/ systems (audit trails, user groups, system administration)Provide ... providing quality oversight over the validation and qualification activities for equipment, systems , computer systems , and processes within a cell therapy… more
- Merck & Co. (Rahway, NJ)
- …in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or upgraded instrumentation or software ... to ensure 21 CFR part 11 ComplianceSupport standardization activities for System Development Life CyclePrepare, review, and approve documentation such as master… more
- Merck & Co. (Rahway, NJ)
- …assigned studies such as IRT & Microsoft PowerApps. -Works directly in the SAP system to ensure a robust and consolidated forecast for CFGs is maintained. --Report ... and clinical customer relationship management.-Technical Proficiency: familiarity with supply chain systems and software (eg SAP or Oracle) and demand planning… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OverviewThis position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy Manufacturing on ... pipefitting, and millwright activities associated with the related mechanical systems , utilities, and process equipmentPerform minor upgrades and installations of… more
- Merck & Co. (Durham, NC)
- …CMMS system platforms and route engineering change requests through CMMS system .Expand knowledge into other systems , capable of managing change in the ... or finished pharmaceutical environmentExperience in automation and manufacturing execution systems (MES), process modeling and process improvement.Mechanical functionality and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … development. Act as R programming SME and functional representative of R systems and infrastructure to identify system and technology development needs and ... to provide statistical programming technical support related to R programming, R related system and technology. Develop and drive R programming, package, and R shiny… more
- Merck & Co. (Boston, MA)
- …requests with Library team membersManaging access to external information systems such as databases, literature platforms, and pharmacopoeiasCollecting and reporting ... with Library team members on user acceptance testing and to system development lifecycleEducationDegree in life sciences, information science, or related scientific… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at ... This individual will support electronic batch record (EBR) updates and system improvements, support applicable process and facility updates, and support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the administration and operational support of Daiichi Sankyo's Veeva CRM system within IT. They'll collaborate with various sales and marketing customers to ... API requirements (no development experience required) in and out of Veeva CRM system .- Documentation: Document various system related documentations such as … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in overseeing the development, validation, implementation, and integration of GxP-regulated systems across the organization. This position ensures that all global ... systems , electronic records, validation processes, and regulated applications meet...11, Annex 11); possess a strong understanding of IT system architecture and cloud-based environments.Manage third-party vendors, system… more
- Merck & Co. (Durham, NC)
- …Site Business Partners.Initiate, Review or Approve changes in the Calibration system (ProCal).Manage approved vendors for calibrations not performed by site ... to ensure appropriate instrument turnover to site.Expand knowledge into other systems , capable of managing change in the pursuit of continuous improvement.Support… more
