- Formation Bio (New York, NY)
- …to join the Data Platform team at Formation Bio to help transform Electronic Health Records (EHR) data into structured, analytics-ready assets. In this role, you'll ... logic, assumptions, and data lineage in collaboration with metadata and cataloging systems . Contribute to the evolution of the Data Platform by helping define… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …long-term objectives.Ability to identify/remediate gaps in processes.Operational experience with electronic quality systems is required.Proficient with using ... 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
- Aequor (Athens, GA)
- …sites / activities. Major activities include: the subject matter expert for electronic document management systems and migration of records from legacy ... systems . Electronic Document Management (controlled documents, regulatory submission documents): Create...systems . Must be able to follow precise computer system instructions with high attention to detail and minimal… more
- Twist BioScience (South San Francisco, CA)
- …system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS, QMS) using ... Sr. Director, Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated Manufacturing… 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. (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. (Omaha, NE)
- …using standard problem-solving tools and methods to resolve machine and system issues.Experience with pneumatic and electronic controls, wiring methods, ... be responsible for installing, maintaining, troubleshooting, and repairing equipment, utility systems , and facility needed for the storage, packaging and shipping of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Supply Chain, Operations, QA, Reg CMC, and IT. This individual will support electronic batch record (EBR) updates and system improvements, support applicable ... will be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems across the organization. This position ensures that all global systems , electronic records, validation processes, and regulated applications meet ... defining and driving the methodology, approach, and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy,… more
- Merck & Co. (Durham, NC)
- …monitoring during processing and records results in the computerized database system . Provides timely delivery of samples and other materials as required ... Aseptic Processing, Chemical Plant Operations, Computer Literacy, EHS Training, Electronic Troubleshooting, Environmental Controls, Environmental Monitoring, Equipment Maintenance, Equipment… more
- Repligen (Rancho Dominguez, CA)
- …9001 and GMP manufacturing standards. Proficient in SolidWorks/CAD, MS Office, and electronic file management systems . Familiarity with single-use systems , ... device manufacturing, with deep expertise in Tangential Flow Filtration (TFF) systems , process engineering, and equipment qualification, preferably within GMP or ISO… more
- Aequor (Thousand Oaks, CA)
- …(eg, EDC systems , data integration platforms, data flow). Participate in system design, and user acceptance testing. Role model with staff on new technologies ... proven track record of delivering on complex technology implementations. Familiarity with Electronic Data Capture (EDC) systems (eg, Veeva, Medidata). Knowledge… more
- Repligen (Hopkinton, IA)
- …documentation in a timely manner to meet established deadlines (paper and electronic ).Maintains related database systems , if applicable, logs and complete ... is responsible to actively participate in the Repligen ISO 9001 Quality Management System . This role is responsible for assisting the document control department in… more
- Merck & Co. (Durham, NC)
- …lab initiatives, have a strong understanding of Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit support. ... requirements toward analytical testingCapability to function effectively within an automated/ electronic laboratory environmentThis position will be located at the… more
- Genmab (NJ)
- …submission-ready labeling documents; Maintain and track labeling documents in the electronic system as appropriate.Participate in the development and maintenance ... with MS-Office Suite and Adobe Acrobat application and ability to work in electronic document management systemFor US based candidates, the proposed salary band for… more
- Everglades Equipment Group (Fort Myers, FL)
- …Certification in automotive air-conditioning Read hydraulic schematics and diagnose hydraulic system faults Read electrical schematics and diagnose electronic ... variety of skills from basic mechanical to complex technical diagnostics of modern computerized systems . Must be able to provide own basic tool kit. Must be able to… more
- Aequor (Hicksville, OH)
- …to Stock (RTS) or paper transfer using scanning guns. Sets up electronic marquees indicating the product information for production lines. May calibrate ... of pharmaceutical products. Basic knowledge of computer applications, including SHAPE system and Microsoft Office. Proficient in basic level arithmetic. Working… more
- Merck & Co. (North Wales, PA)
- …clinical trial programming including data steps, procedures, SAS/MACRO, SAS/GRAPH; systems and database expertise.Experience leading large and/or complex statistical ... experience at the leadership level including the development of electronic submission deliverables.Designs and develops complex programming algorithms.Ability to… more
- Aequor (Thousand Oaks, CA)
- …of quality systems . Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality ... and operations according to company procedures. Experience working with Quality Systems , Strong organizational skills and ability to manage multiple tasks at… more
- Twist BioScience (South San Francisco, CA)
- …Safety Data Sheets (SDS), SOP, and work instructions Familiarity with Quality Management Systems and electronic document control systems (eQMS) Experience ... with Google Suite and/or MS Office Products required. Experience with Master Control, Atlassian Confluence and/or JIRA preferred. Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)… more
