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Or minimum of 4 years of experience in GMP quality control or manufacturing + Ph. D. degree in microbiology, biochemistry or a related life science. Minimum of 10 years of experience in GMP quality control or manufacturing + Bachelor of Science degree in microbiology, biochemistry or a related life science.
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Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity.
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QA, quality assurance, cell therapy, gene therapy, CAR-T, cell and gene therapy, cell culture, mammalian cell culture, investigation, deviation, CAPA, non conforming, batch record, batch record review, technical writer, quality control, medical, dental, vision, 401k.
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The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.
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The successful candidate will be responsible for supporting all aspects of quality management, assurance, and control at the Isolere Facility. Reporting to Isolere’s Quality Manager, the Quality Specialist will perform QA/QC review of manufacturing and testing records as well as inspection of materials received, finished product, and work in process of Isolere products, ensuring conformance to product requirements and specifications.
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A working knowledge of motion control in machine design, including appropriate selection and integration of bearings, gear systems, position and rate sensors, rotary and linear actuation, spring/damper integration and motor control.
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Experience with the Installation, Commissioning and Qualification of automated control systems to follow cGMP, GAMP, and quality requirements. Background in the successful design, development, installation, commissioning and turnover of process automation systems involving: instrumentation, electrical control panels, PLC/HMI/SCADA or DCS programming and Historian configuration.
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10+ years relevant working experience, within an established biotechnology organization in analytical development and/or quality control, with experience in cell and gene therapy, vaccines, and/or complex biologics.
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Familiarity with open-source programming languages (i.e., Python, R) to perform data analysis, management, transformation, quality control, and/or statistical analyses. Attention to detail as the candidate will be responsible for preparing, using, and conducting quality control on large and diverse datasets.
$75,000 - $91,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Graduate of an Electronics& Instrumentation course (2 years minimum), from a recognized technical institute with subjects covering electronic and instrument control systems, and component maintenance OR Completion of a formal 5-year Instrument Technician apprentice program, including work on electronic and instrument control systems, and component maintenance OR Equivalent military training.
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Familiarity with regulatory requirements and standards, such as FDA, GMP, and ISA. Certification in DeltaV or related control systems. The ideal candidate will be responsible for overseeing the design, implementation, and support of Emerson DeltaV Distributed Control Systems (DCS) in various projects.
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Demonstrated background in support of GMP Quality management systems, The Quality Specialist II provides support to the overall Quality Assurance program at the site. Contributes to the development, implementation and execution of quality systems programs, as required.
$80,000 - $81,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Perform professional civil engineering work including design of erosion and sediment control measures in compliance with state requirements, SPCC plans, site grading using AutoCAD Civil3D, hydraulic systems (closed and open conduits), hydrologic analyses, and stormwater management facilities.
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Assist in the adherence of Quality Control/Quality Assurance policies. Advanced knowledge of civil engineering concepts, principles, theories, and methods required to plan, design, and engineer site and land development projects to include grading, erosion control, phasing, environmental, storm-water, water, wastewater, site design, zoning analysis and roadway plans at a minimum.
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Write clean, logical, well-commented Python and/or R code for research-based projects, data management, quality assurance/quality control, and automation opportunities. Conduct quality control and assurance.
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quality control jobs Company: Farm Fleet Blain Supply Inc in Durham, NC
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