- 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
- 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
- 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
- Merck & Co. (Durham, NC)
- …Skills:Building Automation Systems , Computerized Maintenance Management Systems (CMMS), Electrical System Troubleshooting, Equipment Maintenance, ... PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical… more
- Merck & Co. (Rahway, NJ)
- …(Word, Excel, PowerPoint, Teams, etc.) and ability to adapt to learning other electronic systems to support day-to-day work. - Preferred Experience and Skills: ... performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating… more
- Merck & Co. (Durham, NC)
- …PM's, installing new equipment, documenting work using a computerized maintenance management system (SAP) and other duties as requested by the Coach or Mechanical ... ability to follow complex instructions and use our Manufacturing Division's business systems (SAP, ADP eTime, etc.)Physical requirements - Must be able to lift… 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
- Lundbeck (Bothell, WA)
- …chemicals, and consumables including ordering and receiving using Lundbeck procurement system Process biohazardous waste for pick-up Media and buffer preparation ... and characterization Timely and error-free completion of data entry in electronic lab notebooks (Benchling) Flexible schedule for daily reactor and shake-flask… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …prepare manual checks as needed, maintain and review timesheets submitted through the electronic time collection system , compile and submit tax and unemployment ... confidentiality of sensitive information.Previous experience with an automated payroll system is required, as is professional-level experience with Microsoft Office.… 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
- 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
- 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
- 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
- Aequor (West Greenwich, RI)
- …procedures. 3. Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks. 4. Operate and maintain ... specialized laboratory equipment and instrumentation. 5. Participate in laboratory investigations and audits as necessary. 6. Perform general laboratory housekeeping activities. 7. Maintain training compliance and proficiency. 8. At all times, comply with… 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
- 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
