- Legend Biotech USA, Inc. (Raritan, NJ)
- …to identify/remediate gaps in processes.Operational experience with electronic quality systems is required.Proficient with using Microsoft Office applications ... 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… more
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an...Hybrid Work Model Effective September 5, 2023, employees in office -based positions in the US will be working a… more
- Merck & Co. (Durham, NC)
- …This support position will focus on leading investigation of Electrical system excursions, engineering maintenance, design system improvements and optimizations ... detailed understanding of design, construction, control and maintenance of building systems and process equipment. Provides technical support and training to… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... such as boilers, chillers, Cooling towers, air compressors, waste deactivation systems , HVAC, clean steam, WFI.- Develops Standard Operating Procedures (SOPs) and… more
- BioAgilytix (Durham, NC)
- …to add/move/change user accounts and workstations; addresses issues with corporate systems such as printers, phones, and audio-visual (AV) equipment; and supports ... related to the overall corporate infrastructure and validated computerized systems .Essential Responsibilities Prioritize and respond to end user service requests… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... perform routine maintenance tasks, work with and troubleshoot complex process systems , including but not limited to:Utility Equipment (eg boilers, chillers, Cooling… more
- Repligen (Clifton Park, NY)
- ….Familiar with GMP, FDA, NEC, and NFPA70E compliance standards.Proficient with MS Office Suite; experience with CMMS systems and CAD/SolidWorks a plus.Knowledge ... and emergency repairs across mechanical, electrical, pneumatic, hydraulic, and utility systems .Serve as SME for critical systems ; guide troubleshooting and… 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
- 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)
- …application designed to create a frictionless flow of data from source systems to regulatory documentation.- Under the guidance of dCMC Leadership, the Senior ... application by identifying, implementing and enforcing data standards from key source systems ; contributing to data model development; and assisting in evolving data… more
- Twist BioScience (South San Francisco, CA)
- …RoleWe are seeking an experienced Staff Engineer specializing in Salesforce (SFDC) and systems integrations to join our technology team locally at the South San ... Francisco, California office . The ideal candidate will serve as a technical...and deep understanding of integration to eCommerce and ERP systems to ensure scalable, robust, and flexible cross-functional solutions… more
- Eisai, Inc (Atlanta, GA)
- …from you. : The Area Business Leader (ABL) will engage with assigned health systems for Eisai's oncology portfolio and manage a team of sales professionals. The ABL ... C-suite, administrative stakeholders, key influencers, and decision-makers within health systems ) within the market place.Collaborate with regional leaders and… more
- Merck & Co. (Boston, MA)
- …Development, Stakeholder Engagement, Stakeholder Relationship Management, Strategic Planning, System Designs, Systems Development Lifecycle (SDLC)Preferred ... of tools within our Company's ecosystem and with upstream/downstream systems .Apply industry standards and ontologies to develop FAIR (Findable, Accessible,… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The associate director will be a technical subject matter expert on the ... global and site-specific projects related to combination products and drug delivery systems .Ensure that all activities are conducted with the highest regard for… more
- Merck & Co. (Rahway, NJ)
- …of Microsoft Office Suite (Word, PowerPoint, Excel), Veeva, and other systems used by field medical teams, with the ability to interface effectively with ... Affairs Team (MAT) meetings.Establish and maintain strategic partnerships with Health Systems (HS) by leading RMSD medical account planning initiatives to enhance… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and ... Systems COE the Director, Logistics and Distribution Technology will...for shock and vibration as well as thermal protection system testing and qualification and leading execution of qualification… more
- Eisai, Inc (Nutley, NJ)
- …area Strong analytical skills and report writing skills Experience with GxP systems including computer system validation and associated regulations, recommended. ... and inspection management and oversight of the Quality management system . This role is responsible for Good Clinical Practice...days per week working onsite in our Nutley, NJ office . Eisai Salary Transparency Language:The base salary range for… more
- Merck & Co. (Rahway, NJ)
- … System , Inventory Management, Mechanical Testing, Medical Device Quality Systems , Negotiation, Project Management, Quality Management Systems (QMS), ... ImplementationOversee the selection, implementation, and optimization of inventory management systems (IMS) and automated solutions specific to DD&T assets.Integrate… more
- Merck & Co. (Rahway, NJ)
- …other pharmaceutical companies).Ensuring that essential elements of the quality management system are in place for studies conducted in partnership with ... and Head of CQO, maintain and QC the global inspection tracking system that tracks all GCP Regulatory Health Authority inspections, findings, responses and… more
- Merck & Co. (Irving, TX)
- …production associates to meet production schedules in compliance with the Quality System , EHS and company policies while ensuring that equipment and material ... in manufacturing, distribution, or operations environments. Experience using Microsoft Office products, Excel knowledge required. Experience with enterprise resource… more
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