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Reporting to the Global Quality Engineering Director, the Supplier Quality Specialist will achieve ALAM goals in the areas of manufacturing quality, technology advancement, productivity, off-spec elimination, non-conformance elimination, customer satisfaction, and cost reduction.
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Reporting directly to the Senior Manager of Quality, this position collaborates closely with External Manufacturing Organizations (EMO), spanning pharmaceuticals, medical devices/combination products, consumer products/OTC, and biologics sectors, ensuring adherence to cGMP regulations and Bausch Health requirements.
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Extensive experience in cell therapy commercial cGMP operations with end-to-end know-how to drive changes/improvements and capacity plans in a global manufacturing network. This individual will be responsible for a global operational strategy and investigations lead / owner for a best-in-class high volume marketed CAR-T product as part of a multi-site global manufacturing network.
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Works in collaboration with Global Logistics and Import/Export Compliance teams to coordinate specialized shipments. The Manager - Warehouse reports to the Associate Director-Warehouse and is responsible for technical support for activities within Lilly Branchburg Manufacturing Warehouse Group.
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It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
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In this position, you will be part of a critical team tasked to support the on-going operations of the Global Nestlé Product & Technology Center, Nestlé Health Sciences Pilot Plant, Research & Development Labs and the office building for the U.S. Headquarters of Health Sciences.
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The Manager of Quality Operations will provide Quality and Compliance oversight to Contract Manufacturing and Packaging Organizations (CMOs) within a cross-functional team and Product Disposition functionality for drug products manufactured by CMOs. The primary responsibility of this role is to ensure that the CMOs are operating in compliance with all Bristol Myers Squibb (BMS), applicable Food and Drug Administration (FDA), and international regulatory standards.
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At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people by solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities.
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The HORIBA Group of worldwide companies provides an extensive array of instruments and systems for applications ranging from automotive R&D, process and environmental monitoring, in-vitro medical diagnostics, semiconductor manufacturing and metrology, to a broad range of scientific R&D and QC measurements.
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IPS, a Berkshire Hathaway Company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
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Firmly grounded in the rich heritage of Italian manufacturing excellence and an innovative perspective on the fusion of eyewear and fashion, they have transitioned from a humble "artisanal workshop" to establish themselves as prominent global leaders in the eyewear industry.
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Works closely with quality, manufacturing, Global Regulatory Affairs (GRA), and technical staff from global locations within industrial network, contract manufacturing organizations (CMOs), and alliance partners to author high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers.
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This exciting new role works with the CAR-T Assets Maintenance & Calibration Manager and will be tasked with improving the Reliability and Maintainability of the assets supporting manufacturing operations onsite.
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The QC Microbiology Specialist, Lentivirus Vector (LVV) CAR-T Manufacturing is an exempt level position with responsibilities for performing routine Environmental Monitoring sampling of the LVV facility to support clinical trials and commercial operations in a controlled GMP environment.
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Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams.
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manufacturing global jobs in Somerset, NJ
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