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Marmon Industrial Water designs and manufacturers water and wastewater treatment equipment solutions, under the brand names Graver Water Systems and Ecodyne. Working knowledge of PLC/DCS systems, SCADA, communication protocols popular in North AmericaUnderstanding of process instruments and instrument installation, hook up, tuning, etc.
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A major in either Math, Engineering, Computer Science, Computer information Systems, Cyber Security, Management Information Systems (MIS) and Data Science, and others. We will have you work on rotational assignments for a variety of experiences including Full- Stack development, Cloud, Data, and products like Salesforce, Mosaic, Duck Creek, etc.
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Working knowledge of scheduling software and systems, and inventory management systems, Blue Mountain RAM and Maximo preferred. Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
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Knowledgeable in various technical and business systems (i.e., SAP Hana, SAP GRC, Linux, iSeries, Windows/AD, Workday, Salesforce, and Cybersecurity). Evaluate security and internal controls over systems to ensure data integrity and the safeguarding of assets.
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Experience with expediting purchase orders and using payable systems such as Ariba and Concur. The coordinator is an integral member of the EHW team and provide support to integrated members including the Occupational Health Nurse (OHN), Dedicated Workplace Support (DWS/EAP) and Wellness.
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This position is subject to both inside and outside environmental working conditions, including temperature changes, outside weather conditions, slightly elevated ambient noise levels, and minor atmospheric conditions affecting skin or respiratory systems, such as fumes, odors and dusts associated with internal and external service station/convenience food and petroleum dispensing operations.
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Initial and ongoing training will include, but is not limited to, Property and Casualty Insurance principals, Chubb product offerings and all applicable systems and tools that will enable you to be a Champion of Service.
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This includes documentation control, change control, deviation management, and CAPA (Corrective and Preventive Action) systems. Position requires on-site presence at companies' HQ Essential Duties and Responsibilities Conducting Training: Developing and conducting training programs for personnel on GMP and GDP requirements, quality systems, and relevant procedures to ensure understanding and compliance throughout the organization.
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Collaboration: Attend customer facing meetings to communicate standards and directions, as well as advise on technology solutions and capabilities in CRM. Collaborate with external technology vendors and internal IT teams to ensure the successful integration of Veeva CRM and Omnichannel Marketing features with other systems and applications such as C360, data warehouse, marketing cloud, etc.
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Position Summary: The Director, Clinical Systems and TMF Operations is a member of the Clinical Business Operations team within the Development Operations organization and is responsible to provide strategic leadership and oversight of Trial Master File (TMF) Operations, Records Management, and Clinical Systems & Technology (CS+T) utilized across clinical programs.
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Expertise with MS Office, Word, Excel and document management systems such as Veeva or Documentum is a plus. The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports.
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Hands on experience with quality systems in a regulated environment, including change control, CAPA and investigations. Attention to detail and familiarity with batch record review process and FDA quality standards.
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Developing and Maintaining Quality Systems: Establishing and maintaining comprehensive quality systems in compliance with GMP and GDP regulations. Continuous Improvement Initiatives: Leading or participating in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes, driving a culture of quality and excellence within the organization.
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Audit experience conducting a variety of audit types, including internal systems, vendors, TMF and investigator site audits. Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.
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Experience with Veeva (Quality Docs, QMS and Training modules) a plus. Global Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expandingLooking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization.
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