• Catalent (Harman, WV)
    …regulations (21 CFR Part 600s) or EU GPs, a plusProficient with electronic systems , including developing and producing reports.Experience with data analytics ... POSITION SUMMARY The Director, Quality Systems is responsible for the management and oversight...quality metrics for Senior Management review, and other quality system functions, as needed. The Role Provides strategic direction… more
    HireLifeScience (03/27/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …end users guidance on Computer Systems utilized to support quality management system activities such as Electronic Document Management System , and ... not necessarily be limited to, the following: Represent Digital Systems QA as a GxP computer system ...Digital Systems QA as a GxP computer system validation expert and provide oversight and guidance on… more
    HireLifeScience (03/12/24)
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  • Merck & Co. (North Wales, PA)
    …and manipulation; experience with sampling strategies for large databasesUnix operating system experience; SQL experience; systems and database experienceThrives ... multiple programming languages including SAS and R to efficiently manipulate electronic healthcare databases to discover disease prevalence and risk factors,… more
    HireLifeScience (03/08/24)
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  • BioAgilytix (Durham, NC)
    …strategies to protect archived data and materials Be fluent with all electronic data systems to ensure appropriate archival Implement disaster recovery ... Responsibilities: May be the primary contact for alarm notifications by the electronic monitoring system specifically for the archive room Scan and… more
    HireLifeScience (03/18/24)
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  • BioAgilytix (Boston, MA)
    …metadata to confirm consistency between the tube labels, study paperwork and electronic sample management systems (eSMS)-Accessions samples into LIMS -Imports ... electronic data into electronic sample management system (eg FreezerPro)-Resolves discrepancies, with responsibility for investigating and correcting sample… more
    HireLifeScience (03/19/24)
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  • Merck & Co. (Rahway, NJ)
    …repairs.Document Maintenance activities using SAP Plant Maintenance system .Utilize electronic technologies; electronic work order systems , e-training, ... not limited to: Layout, assemble, install, alter, modify, repair, and test pipe systems that carry site utilities (water, steam, air, or other liquids, or gases)Read… more
    HireLifeScience (03/25/24)
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  • Merck & Co. (Rahway, NJ)
    …and the device constituent part of a Combination Product. Manage activities within electronic computer systems , eg, Material Management Systems (SAP), ... and build QMS capabilities that touch every aspect of our business processes, systems , and data. - The Associate Director will collaborate and interact with… more
    HireLifeScience (03/16/24)
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  • Lundbeck (Bothell, WA)
    …experience Prior people management (ie direct reports) experience Prior Lab IT experience with electronic systems (such as ELN, LIMS, SDMS or other related ... biotech or pharmaceutical company Prior Lab IT experience integrating Lab equipment with electronic systems Proficient in Windows/Office 365, Apple iOS, MS Visio… more
    HireLifeScience (01/20/24)
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  • Merck & Co. (Rahway, NJ)
    …strong attention to detail in completing GMP documentation, proficiency in electronic systems , and participation in continuous improvement projects.-Positions ... to maintain good manufacturing practice (GMP) operations, using paper-based and electronic systems . Maintains detailed knowledge of process equipment and… more
    HireLifeScience (02/28/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …personnel and material flows. Provide input to stakeholders regarding Operations electronic system utilization. Support Management team to implement improvements ... 2+ years Biotech/Pharmaceutical experience or equivalent industry experience. Understanding of electronic manufacturing systems (MES, LIMS, SAP, etc.). Good… more
    HireLifeScience (02/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …the DMP and day-to-day management of DS Safety Notification Letter (SNL) System . Electronic Data Capture (EDC) Responsibility: In conjunction with Data ... for PV Safety Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and… more
    HireLifeScience (03/19/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Oversight Plans, day-to-day management of DS Safety Notification Letter (SNL) System and presentations and documents. Electronic Data Capture (EDC) ... Plans and may perform final review. This position provides input on electronic data capture (EDC) Safety report outputs, reviews clinical study and post-marketing… more
    HireLifeScience (03/19/24)
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  • 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
    HireLifeScience (03/23/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …compliance. This includes implementation, optimization and management of the labeling Electronic Document Management System (EDMS) and the labeling milestone ... of global labeling development and quality review processes, templates, metrics, and systems , while ensuring compliance with FDA, EMA, PMDA and other Health… more
    HireLifeScience (02/23/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA). Operational experience with electronic quality systems . Experience with Document Management Systems ... GMP environment. This role will ensure compliance within the document management system , document storage & retention, and document issuance & reconciliation. Key… more
    HireLifeScience (01/09/24)
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  • Legend Biotech USA, Inc. (Raritan, NJ)
    …of Quality systems . Experience in management of retain samples using electronic systems (eLIMS). Candidates must be able to accommodate shift schedule. ... to the QC laboratory and ability to identify gaps in processes or systems . Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)… more
    HireLifeScience (03/28/24)
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  • Merck & Co. (Rahway, NJ)
    …Suite (Word, Excel, PowerPoint, Teams, etc.) and ability to adapt to learning other electronic systems to support day-to-day work. - - Preferred Experience and ... Performs audits of batch documentation, data, information, procedures, equipment and systems , and/or facilities to ensure the compliance with Standard Operating… more
    HireLifeScience (03/23/24)
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  • Novo Nordisk Inc. (Plainsboro, NJ)
    …skills (MS Office and clinical trial systems ) and adaptability to new systems . Working knowledge of electronic trial master files and clinical trial ... assigned clinical trials, document management and management of clinical trial management systems and archiving systems . Relationships Reports to a Manager (or… more
    HireLifeScience (03/26/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …Training and curricula development experience including oversight and administration of validated electronic systems such as LMS or other quality management ... project teams. This position has advanced skills in technology systems , including word processing software and data management software,...ensure New Hire has a sufficient access to the system and information to do that work.- Review the… more
    HireLifeScience (03/07/24)
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  • Aequor (Bothell, WA)
    …solutions without direct authority. A self-starter with an ability to manage electronic systems with minimal training and supervision. Requirements - Minimum ... post on sharepoint, schedule reviews, collect and resolve feedback. Knowledge of electronic document management systems (EDMS) to complete workflow of document… more
    HireLifeScience (03/24/24)
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