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The Facility & Reliability Engineer will also support the successful operation of facility, laboratory, and business functions at multi-use GMP sites within client, Summit West Cell Therapy Operations, through interaction with internal customers and external service providers.
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Generates SOPs and Work Practices within Celgene’s Document Management System and electronic work plan template and measurement data templates to establish the Use, Maintenance and Calibration plans for GMP equipment.
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Job DescriptionThe Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.
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Years of experience in Pharmaceutical Manufacturing preferred, at least years combined of relevant experience in quality-based roles including experience in GMP and/or laboratory operations required.
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Experience of GMP document review, Quality Management System maintenance, quality auditing. The role requires a thorough knowledge of laboratory practices, including testing and OOS investigations, and QMS systems such as Deviations, CAPAs, and Change Controls.
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Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes. The Equipment Technician, Equipment Commissioning & Qualification Operations supports the successful operation of laboratory, clinical and commercial manufacturing operations at their home site through interaction with internal team members and internal customers as well as external service providers.
ExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Experience with the analysis and GMP reporting process of OTC drugs, cosmetics, dietary supplements, and/or botanical products. They provide a comprehensive range of analytical laboratory services to the pharmaceutical, nutraceutical, and cosmetic industries.
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Assist chemists in non-GMP and cGMP kilo lab(s) with batch set-up, chemical supply staging, preparative chemistry processing, area clean up and vessel clean out. – is seeking a highly qualified candidate to serve as Chemical Operations Scientist 1, reporting to the Associate Director or Director of Process Chemistry or GMP Operations, in their central NJ location.
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The team consists of approximately 50 members, with expertise in a variety of topics like microbiology, cell culture, purification, engineering, small-scale laboratory operations and process and system validation.
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The QA Validation Specialist will be responsible for management of the GMP quality assurance oversight of Qualification, Validation, in relation to Facility Equipment, Computerized Systems, Laboratory systems in order to meet our regulatory requirements in Millburn, NJ.
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Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP.
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Escorts Field Service Engineers performing calibration, preventative maintenance, performance verification, and repair activities in both laboratory and manufacturing areas. Work with Equipment Commissioning and Qualification Engineers to maintain organization of storage and laboratory areas utilized by Equipment Commissioning and Qualification.
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Chemists in non-GMP and cGMP kilo lab(s) with batch set-up, chemical supply staging, preparative chemistry processing, area clean up and vessel clean out. all company, site, and laboratory Environmental, Health and Safety (EHS)-related protocols, processes, guidelines, and SOPs. Actively participate in EHS discussions with peers and management for continuous improvement of EHS practices.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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Serve as SME for the GMP regulatory inspections, specifically for qualification and validation matters. Represents site QA Validation SPOC (Single Point of Contact) for Facility Equipment and systems, Computerized Systems, Laboratory systems and participate on SOP authoring/review and implementation to site.
$88,000 - $132,000 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago
gmp laboratory jobs in Summit, NJ
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