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Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), ValGenesis, ERP (SAP) and Laboratory Information Management (LIMS) systems. Primary responsibilities include: assistance with area batch record reviews and applicable product release, participation in the Change Management, Investigation, and CAPA systems, maintaining the site's compliance with Zoetis Quality standards, review and approval of action items, performing internal audits and support and quality oversight of ABI/BPM/Pharmaceutical manufacturing, and all packaging operations within Zoetis Lincoln Operations.
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This hybrid onsite and remote role will provide technical support for various LIMS / LabWare along with GxP and manufacturing applications such as Werum/Koerber PAS-X, Blue Mountain RAM, TraceLink, Dell Boomi, and Optel Vision Systems in a regulated, validated environment.
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Substantial understanding and knowledge of enterprise information systems such as ERP, PLM, CRM, QMS, etc (such as JDE, SAP), PLM (TeamCenter, Agile), MES (such as CAMSTAR, APRISO, etc), CRM (such as Salesforce.com) APS (such as JDA, Manugistics, i2, SAP), QMS (such as Pilgrim, TrackWise, Master Control), LIMS (such as Labware), Calibration and Maintenance (such as Blue Mountain or Maximo) preferred.
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Desired experience with laboratory informatics software such as a networked Chromatography Data System (CDS), Laboratory Information Management System (LIMS), Electronic Laboratory Notebook (ELN), or Scientific Data Management System (SDMS.
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Knowledgeable about QMS (Quality Management System), DMS (Document Management System), MES (Manufacturing Execution System), LIMS (Laboratory Information Management System), and WMS (Warehouse Management System) related information systems, with practical experience in implementation, validation, and operational maintenance.
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Real time documentation within data sheets and LIMS following appropriate test methods, SOPs and ALCOA+ principles. 1 - 3 years (Analyst) / 5+ years (Sr. Analyst) relevant bioanalytical assay experience including flow cytometry and/or ELISA methods.
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Collaborate with the Computational Biology team on programmatic data capture, ensuring complete integration with LIMS capturing clean data. Experience with LIMS systems Benchling, CORE LIMS.
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Expertise in integrating Cloud infrastructures with third-party systems (e.g., Netsuite, EHRs, LIMs). Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment.
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Completion of the study set-up within a Laboratory Inventory Management System (LIMS - StarLIMS). Keep study account information up to date within a Laboratory Inventory Management System (LIMS - StarLIMS) and Customer Portal.
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Deep knowledge of Life Sciences Research and Early Discovery (R&ED) data & analytics in Target Screening, Lead Optimization, Vaccines, Lab - Dry & Wet, Instrumentation, LIMS, CMC and other relevant areas.
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General knowledge ofthe Laboratory Information Management System (LIMS) is needed to reviewanalysis results and provide general customer support. Working knowledge of a broad range of plant medicineproducts, processes, and cultivation preferred (e.g. Cannabis, Hemp, CBD andFungi.
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A minimum of six years' experience in providing complex consultative services in the following focus areas: information strategy, big data architecture, information/data governance, master data management, data quality, data integration particularly in a life science or healthcare setting.
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Assisting in the strategy and implementation of Master Data Management, Data Governance, Enterprise Data Management, Enterprise Content Management and Knowledge Management using modern techniques and approaches.
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High level of proficiency in the use of a LIMS. Experience using a LabWare LIMS. Broad knowledge laboratory testing techniques and instrumentation such as spectroscopy, mass spectrometry, spectrophotometry, microscopy, electrochemistry, filtrations, extractions, gravimetry, chromatography.
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Technology environment the consultant will be working in:•Waters Empower, HPLC•Malvern, Particle Size Analyzer•Karl Fischer Method•LabVantage LIMS Consultant's day to day responsibilities:•Bench testing of pharma products using Empower HPLC and Malvern Particle Size Analyzer•Performing wet chemistry testing including viscosity, pH and dissolution.
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