- Aequor (Houston, TX)
- …improvement initiatives based on identified recurring root cause. Serves as the Quality Record (PR) Subject Matter Expert ( SME ), Level I, for the ... the initiation, investigation and completion of Minor process deviations o Demonstrates technical writing for the educated but uninformed reader, translate simple to… more
- Merck & Co. (Rahway, NJ)
- …CAPAs. Support quality risk management activities as facilitator, project lead and/or quality subject matter expert . Proactively identify, execute and manage ... of the clinical supply QMS through participation as topic team member and/or subject matter expert . Represent Development Quality on inter-departmental and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …effective compliant training performance leading to sustained right first-time executionServe as subject matter expert for Compliance & Training ... in the treatment of multiple myeloma.Legend Biotech is seeking Technical Trainer as part of the Technical ...seeking Technical Trainer as part of the Technical Operations team based in Raritan, NJ. Role OverviewTechnical… more
- Novo Nordisk Inc. (Durham, NC)
- …what matters. The Position Serve as a Lead & Subject Matter Expert ( SME ) to provide technical expertise supporting site data and digitalization ... and digitalization efforts with respective complexity (according to the technical development pathway) and with little to no guidance...MES, SAP, PI Historian) Serve as a Lead and SME in supporting audits & inspections for specified AMS… more
- Merck & Co. (Millsboro, DE)
- …with the USDA, internal MAH departments or international permittees, where applicable.May serve as subject matter expert in regulatory matter (s), such as ... regulations and product license filings, including but not limited to technical bulletins, journal articles, presentations, routine A&P.May prepare and maintain… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Operations team based in Raritan, NJ. Role OverviewThis individual will serve as a subject matter expert for warehouse operations and perform daily warehouse ... comply with cGMP regulations and safety guidelines.Key Responsibilities Serve as a subject matter expert for warehouse operations and perform daily warehouse… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …EBR designs.Participate in design testing, release planning, and demos with partners.Serve as a Subject Matter Expert of MES for CAR-T and site initiatives ... Qualification (IOQ).Define standardizations and update documentation (eg SOPs, WIs, Technical & Design Specifications, and Qualification Protocols) with alignment to… more
- Merck & Co. (Durham, NC)
- …support for the facilityLeading routine process support, projects, and improvement activitiesServing as subject matter expert on the process for daily work ... in Research & Development.We are seeking individuals with strong scientific and technical skills to contribute to the design, development and manufacturing of… more
- Merck & Co. (Rahway, NJ)
- …equipment, conduct functional testing, assist in clinical batch manufacture as an equipment subject matter expert , assist with acceptance testing (FAT, SAT), ... integrated processes such as ultrasonic welding and vision inspection systems.Author technical content of assembly process FMEAs to capture patient and process… more
- Merck & Co. (Rahway, NJ)
- …and processes. Handle small projects as a lead analyst, project manager, or as the subject matter expert . Account and manage for the demands per region ... via managing specific Order to cash process area or subject eg Order management, Customer Master. Based on our...a minimum of 10 years of industry experience. Deep functional/ technical knowledge in SAP SD module and experience in… more
- Merck & Co. (North Wales, PA)
- …documents such as the protocol and other documents as appropriate.May serve as a subject matter expert and/or participate on process improvement teams . ... position, you will have the opportunity to demonstrate your advanced leadership and technical skills as part of a global, cross-functional team. You will build and… more
- Aequor (Devers, TX)
- …for Procurement Activities: Serve as the Sourcing Process Data Lead and transactional Subject Matter Expert and drive best-in-class business processes and ... procurement experience.o Experience with direct procurement.o Experience in a technical , operational, or business role within the relevant industry.o Prior… more
- Repligen (Rancho Dominguez, CA)
- …and the ability to drive projects with minimal oversight.Responsibilities Act as a Subject Matter Expert for TFF and other bioprocessing manufacturing ... technology transfer efforts at our Rancho Dominguez facility. This role provides technical leadership at the site level while collaborating closely with our global… more
- Aequor (Athens, GA)
- …specialist to support GI Development sites / activities. Major activities include: the subject matter expert for electronic document management systems and ... development processes and documentation is strongly preferred, due to the technical nature of the documents being managed. Demonstrated experience managing… more
- Eisai, Inc (Nutley, NJ)
- …evidence generation programs for assigned products. Serve as a medical leader and subject matter expert for relevant external (HCPs, strategic alliances ... and real-world evidence generation. The Medical Director will utilize expert medical/scientific knowledge in assigned therapeutic area to provide strategic… more
- Eisai, Inc (Nutley, NJ)
- …policies. Participate in review of CME grants. Serve as a medical leader and subject matter expert for relevant external (HCPs, strategic alliances etc.) ... experience in the pharma/biotech industry. OR a combination of equivalent education, deep subject matter expertise in relevant area along with a broad overall… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Oversight function in PV deviation management processes, as well as providing SME -level input from the affiliate perspective when required. This role also provides ... maintain a COE for deviation management covering NNI Provides SME support to employees working within the Deviation process,...in area of specialty; pharma experience preferred Specific or technical job skills Strong Root Cause Analysis and CAPA… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …PV Oversight function in PV quality control processes, as well as providing SME -level input from the affiliate perspective when required. This role also provides ... a Center of Excellence (COE) for vendor quality assessment management Provides SME support to employees working within the quality control process, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …fulfills the PV Oversight for NNI Patient Safety processes and as providing SME -level input from the affiliate perspective when required. This role also provides ... a Center of Excellence (COE) for support oversight Provides leadership and SME support to employees working within the support function, including consultation on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: The purpose of this job is to provide statistical programming technical support related to R programming, R related system and technology. Develop ... Lead/contribute to the R programming system development. Act as R programming SME and functional representative of R systems and infrastructure to identify system… more
