- Insmed Incorporated (San Diego, CA)
- …areas of responsibility.Participate in daily and weekly operation meetings and Quality Management Reviews.Own and support stability and sample management-related ... collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and...for the QC stability and sample management operations in support of routine GMP operations at Insmed Gene Therapy.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Support Specialist as part of the Technical Operations team based in Raritan, ... NJ.Role OverviewThe Operations Support Specialist will be part of the Technical Operations...on time in a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with Manufacturing,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an IT Support Analyst - 2nd shift (Contract) as part of the US IT team based in ... Raritan, NJ.Role OverviewThe IT Support Analyst is a dynamic role that bridges the...mobile devicesFollowing-up on client questions and problems (hardware and software ) until resolvedDocumenting issues and resolutions, producing reports when… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy & Operations. This position will support continuous process improvement initiatives, support the annual Global Quality Strategy Plan for R&D PV QA ... and immune disorders. Summary This position is responsible to support the implementation of the Global R&D PV QA...strategy. This position will proactively collaborate with other Global quality colleagues to drive the global QA vision and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to manage DSI QA Functional activities and Global QA activities. This position performs support tasks Head Global R&D PV QA and Global R&D PV QA Leadership members ... as Head Global Strategy & Operations (RDPVMA QA). This position also performs support tasks in which incumbents are expected to understand and apply knowledge of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems implementations in ... requirements for CSV projects. Work within a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and… more
- Aequor (Thousand Oaks, CA)
- …collaboration to develop a metrics digitalization capabilities and information gathering to support MR key activities. Providing the quality management team with ... Quality Management Review Activities Lead coordination activities in support of GxP Management Review preparation including: Coordinate material generation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.Summary This position is responsible to support strategic leadership of QA initiatives within QA and will have the ... primary responsibility to collaborate with, and support the head of Global QA strategy and operations....of N-3 leaders directly reporting to the VP of Quality , and in close collaboration with the QA Training… more
- Eisai, Inc (Nutley, NJ)
- …service partners relative to established SLAs (Service Level Agreement). Oversees SaaS ( Software as a Service) provider system and support performance. Manages ... user needs and business and functional requirements. Lead the development, support and rollout of relevant technologies and platforms. Accountable for overall… more
- Merck & Co. (North Wales, PA)
- …data capabilities and data products. The role influences and ensures timely and high- quality value delivery across all aspects of the data value chain including but ... not limited to a) Data Ingestion of critical organization data to support Sales, Marketing, Market Access, Patient Engagement, Strategy partnerships and Alliances b)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and TE processes- Month end and quarterly disbursement closing processes- Vendor software administration for various ancillary applications- Support of the ... services operation, meeting all deadlines and related responsibilities in support of the enterprise and the strategic vision of...and data operate and are maintained to the agreed quality and service requirements- Leads the planning and deployment… more
- Merck & Co. (Rahway, NJ)
- …Scientist who will develop and utilize advanced computational models to support the development and commercialization of biologics, vaccines, sterile liquids, and ... commercialization, and troubleshooting of large-molecule unit operations.Using modeling solutions, support process development, process characterization, scale-up, scale-down, tech-transfer, and… more
- Merck & Co. (Rahway, NJ)
- …clinical trials to world-wide regulatory application submissions and post marketing support . The incumbent is responsible for the design and maintenance of ... statistical databases that support multiple stakeholder groups which include clinical development, outcomes...project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the… more
- Aequor (Bothell, WA)
- …primary focus of the Quality Control Associate I role will be to support drug product lot release and in-process testing within a cGMP environment. EDUCATION BS ... skills. Computer proficiency as well as the ability to master new software programs. Experience working in a GMP environment is preferred. Demonstrated success… more
- Eisai, Inc (Nutley, NJ)
- …managed service partners are meeting established SLAs. Oversees SaaS provider system and support performance. Manage IT assets and software components and liaise ... user needs and business and functional requirements. Lead the development, support and rollout of relevant technologies and platforms. Accountable for overall… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of multiple sources of data. Responsible for prioritizing team activities and managing quality of the deliverables. Oversee the support and operations of ... closely across regional DSI IT teams and is responsible for the ongoing production support of Commercial and R&D IT systems and applications. The individual in this… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …involves a blend of technical prowess and customer service skills to support , manage, and optimize IT systems and services.Key Responsibilities Providing IT ... support for users as well as C- level individuals...mobile devices.Following-up on client questions and problems (hardware and software ) until resolved.Documenting issues and resolutions, producing reports when… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …creation & revision process for NNUSBPI standards & other documents in order to support Process Tracks, GMP partners & Training partners on site. Expert in local ... change control process to support revision of standards. Interfaces with technical writers at...approval flow in Document Change Control (DCCs) Reviews local Quality Management System (QMS) documents to ensure clear &… more
- Merck & Co. (North Wales, PA)
- …clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible for the design and maintenance of ... statistical datasets that support multiple stakeholder groups which include clinical development, outcomes...project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the… more
