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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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Delegate for meetings to represent manufacturing when management unavailable ; including PA’s and/ or PPA’s. Interaction with groups such as Materials Management, EHS, Maintenance, Metrology, MTS, Quality Control and Quality Assurance (QA.
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Keywords: sample management,GMP, GLP, GXP, GCP, deviations, quality assurance, FDA REMS, quality control, aseptic technique, Smartsheet, CAPAs, risk management, change controls, deviations, biotechnology, pharmacovigilance, pharmaceuticals, quality management, QMS, WWPS, aseptic gowning, good manufacturing practices, good documentation practices, biology, chemistry, life sciences.
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A "hands-on" approach to monitoring production processes versus the MPS is required - including frequent interactions with Engineering Management, Manufacturing Management, Purchasing Management, Quality Management, and Executive Management.
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Manage and validate DeltaV systems, includingconfiguration, change management, and troubleshooting to ensure reliable andefficient operation in a GMP environment. Your RoleWe are seeking a highly skilled and experienced CSV Engineerto join our team in Durham, NC. Develop and execute validation plans, protocols,and reports for computerized systems and commissioning and qualificationdocuments used in pharmaceutical manufacturing, ensuring compliance with FDAregulations (21 CFR Part 11), GxP, and other relevant guidelines.
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Job DescriptionAbout this RoleIn this ASO (Antisense Oligonucleotide synthesis and purification) and OSD (Oral Solid Dosage) Manufacturing Specialist II role, you will be responsible for manufacturing support tasks including technical writing, project management, and process implementation.
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The ideal candidate should have project management skills in an R&D environment with the ability to facilitate optimization of processes to a mature manufacturing state, along with appropriate QA checks and measurements.
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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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Supervise services provided by third party vendors, including but not limited to, landscaping, snow removal, pest control, general building maintenance, office setup requests, and events management.
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Knowledge of warehouse management systems (WMS) and use of RF scanners. Pick, pack, and deliver orders for direct materials used in Manufacturing and Packaging Lines. Handles and maintains flow of materials and products in manufacturing areas according to established guidelines.
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Hydraulics, Diesel Mechanic, Mechanic, Technician, Engineering, Manufacturing, Operations, Technology. Our global sales and service network provides our customers with a local resource for a wide variety of quality material handling equipment, fleet management solutions, warehouse products and support services to meet their needs anytime, anywhere.
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Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. + Manage validation, change control, CAPA and complaint management processes and review boards.
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The PS will liaise with Material Planning, Project Management, Logistics / Packaging, and Manufacturing to remove potential impediments to production plan execution. The Production Scheduler will ensure all production schedules are cascaded to production control staff, manufacturing groups, and organizational leadership.
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Experience working with Manufacturing teams and inventory management. Experience in revenue cycle management and revenue management. This position's responsibilities include managing financial risk, financial planning and modeling, reporting and record-keeping, compliance, guiding financial strategies, leadership and management of the accounting team.
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The Sr. Quality Assurance (QA) Specialist is responsible for ensuring compliance with BioCryst's Quality Systems in support of small and large molecule drug substance and drug product manufacturing/packaging and testing performed at Contract Manufacturing Organizations (CMOs.
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management manufacturing jobs in Durham, NC
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