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Is a dynamic and innovative company providing purpose-built software solutions to address the data management challenges prominent across the BioPharma lifecycle and supply chain. Leveraging more than 30 years of experience in life science informatics, we are uniquely positioned to deliver a portfolio of innovative BioPharma knowledge management technologies to streamline the capture, analysis, reporting and sharing of data required to accelerate the next generation of life-changing therapies.
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This position interacts with departments throughout the organization including but not limited to Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Affairs, Supply Chain, Manufacturing, and Research & Development.
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In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. The Position Act as champion for the Reliability Excellence program & drive improvements into the maintenance processes, to include Reliability, Planning, Scheduling, Spare Parts, Computerized Maintenance Management System (CMMS.
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Experience using electronic calibration management systems such as SAP, Blue Mountain RAM, ProCal, MAXIMO, etc preferred. Demonstrate a high level of organization in task management preferred.
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This Quality position collaborates with Manufacturing, MS&T, Facilities Engineering, Supply Chain, and IT to ensure completion of Root Cause Analysis, CAPAs and Effectiveness Checks (ECs) for Deviations according to cGMP requirements and the company's SOP.
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Functional Operations team: supply chain, purchasing, planning, environmental health, and safety (EHS), project management, logistics, and project management. Lead the operational function for the site including equipment, supply chain, purchasing, planning, environmental health and safety (EHS), project management, logistics, and project management.
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Resolve and escalate issues impacting supply within the daily, weekly, and monthly IPT management processes. Ensure that preventative and corrective maintenance support and calibrations to Clean Utilities, Purification, Fermentation, Sterile Supply and ALUM equipment is performed per schedule and/or business need.
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The Manager, GMP Manufacturing Support, oversees and is responsible for the manufacturing cleaning program, pest control, gowning supply and finite scheduling program across the business.
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Lead, write and review deviations and investigations, including the manufacturing, facilities, supply chain/materials management and support QC deviations as necessary. This includes the manufacturing, facilities, supply chain/materials management and support QC deviations as necessary.
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The right candidate will have a functional understanding of the Supply Chain, Manufacturing, Logistics, Fulfillment and Order Management domains with primary focus on Supply Chain and Manufacturing domain.
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2+ year experience with development and commercialization of custom manufacturing services and supply of clinical and commercial APIs, process development and other associated activities for pharmaceutical clients.
$55,000 - $95,000 a yearFull-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Provide program coordination including status tracking, IP management, document management and data review activities in accordance with, regulatory requirements and Good Clinical Practice and Good Manufacturing Process.
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Includes warehousing and fulfillment of materials and products, transportation, inventory management as well as demand, supply and manufacturing planning. Inventory Management is accountable for the design and execution of demand planning and customer forecasting systems, supply planning, product deployment and expediting processes, and the development and implementation of a stocking optimization model to minimize costs and inventory while delivering on service requirements.
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