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Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP) Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Contract - Trenton Metro Area Duties: Perform QC biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, and client's processes and procedures.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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The Facility & Reliability Engineer will also support the successful operation of facility, laboratory, and business functions at multi-use GMP West Cell Therapy Operations, through interaction with internal customers and external service providers.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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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.
ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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6 MonthsLocation: Pennington, NJAs a QC Raw Material Analyst, your responsibilities:Description: Perform QC sampling and chemistry testing of raw materials under FDA/EU regulations, applicable International Regulations, processes and procedures to support GMP manufacturing.
$48 - $50 an hourExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Perform QC chemistry/biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished biological products (monoclonal antibodies) under FDA/EU regulations, applicable International Regulations, company processes and procedures.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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3-4 years of relevant experience in the pharmaceutical industry on writing laboratory investigations and experience with GMP documentation review, Quality Systems, and Health Authority Regulations.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Familiarity with GLP/GCP/GMP, clinical laboratory regulations, and licensing. Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Keywords: GMP, GLP, GXP, GCP, 21 cfr part 11, full-process manufacturing, CSV, Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls, FAT, SIT, final acceptance testing, system integration testing, engineering, computer engineering.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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The Quality Assurance Quality Management System ( QMS ) Specialist is responsible for maintenance of Kashiv BioSciences’ quality management system located in Piscataway, NJ. The role requires a thorough knowledge of laboratory practices, including testing and OOS investigations, and Quality Management Systems ( QMS ) such as Deviations, CAPAs, and Change Controls.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Responsible for implementing and maintaining a QC analyst certification program and ensuring SOP and GMP training is completed for all laboratory personnel. Responsible for management and oversight of the Quality Control Laboratory to ensure that all aspects comply with GMP, GDP, legal and regulatory requirements.
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Provides technical support to Area Managers and Supervisors in the GMP related aspects associated to the manufacturing/packaging/laboratory processes, e.g., investigations, complaints, deviations, CAPAs, management of changes, APRs.
Full-timeExpandApply NowActive JobUpdated 18 days ago - UpvoteDownvoteShare Job
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Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other BMS standards and regulations. Strong background and experience in laboratory and manufacturing operations.
ExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Maintain and report quality metrics on batch record review and releases. Attend department meetings on batch record review and release, identify opportunities and provides ideas for continuous improvements of batch documentation.
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The GMP Operations branch of Biologics Analytical Research & Development (BAR&D) department within our Analytical Research and Development (AR&D) organization is seeking a highly motivated and innovative leader interested in positively impacting the development and commercialization of our company’s increasingly complex biotherapeutics.
ExpandApply NowActive JobUpdated 6 days ago
gmp laboratory jobs in Trenton, NJ
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