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Manage the R&D quality unit to provide change control, batch release, and deviation management responsibilities for R&D Cell and Gene Therapy Product Development Conduct internal audits of R&D areas as they relate to pre-Clinical trial materials and clinical materials manufacture and management of the R&D internal/external audit schedule.
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Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations. Working knowledge of applicable CTP/SOPs, EHS requirements, and application of cGMP/GDPs.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Working knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs and USP, JP, EP procedures. Contribute to a team setting within the laboratory and potentially with other work teams to increase efficiency, generate cost savings, improve quality, and provide new product support.
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As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. At Takeda, our patients rely on us to deliver quality products.
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This position is responsible for the development and implementation of regulatory strategies and FDA regulated quality assurance activities for pipeline programs to ensure compliance with applicable regulations (GMP, GLP, and GCP.
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VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation and Validation Services to the Pharmaceutical, Biotechnology, Biologics and Medical Device industries.
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Follow established department SOP's, cGMP regulations, and batch record instructions. Ensure that all documentation is in compliance with Quality System Regulation and maintain current knowledge of GMP regulations.
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The Quality Operations Inspector is responsible for providing support to the Company's Quality Operations to ensure that the work perform meets cGMP, and FDA regulatory compliance requirements.
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USC's Keck School of Medicine, Department of Medicine is seeking a dynamic individual to support the process development and manufacturing of cell and gene therapies and other biological products for internal/external users in the university's current Good Manufacturing Practices (cGMP) facility.
$38Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Proficient in cGMP regulations, quality systems and regulatory requirements. Provide quality assurance support across functions (Manufacturing, Supply Chain, QC, Process Development, Regulatory Affairs) and externally to assure compliance and strong relationships.
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Oversee the Supplier Quality Management program, Training, Enterprise systems VEEVA and Delphi, LIMS and Document Control. Extensive experience in GMP manufacturing and compliance with demonstrated knowledge and experience of related quality assurance principles applicable to pharmaceutical manufacturing.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Provide quality systems/assurance support across technical operations functions (i.e. Manufacturing, Facilities & Engineering, Supply Chain, Quality Control, Analytical Development, Product Development/Manufacturing Sciences & Technology) within Neogene to assure compliance to the quality manual and maintain collaborative quality relationships.
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Conduct biological, chemical and physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw material through finished goods including at a minimum; in-process, final container, stability and critical systems testing.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Create and execute project plans for process and assay development and support the transfer of processes to cGMP manufacturing and quality control. As the Associate Director of Process Development, the individual will be responsible for creating protocols and methods for the production of various cell and gene therapy products, procuring the necessary equipment and components for cGMP production, making adjustments to the process and reagents to meet cGMP requirements, facilitating technology transfers, and developing assays for product characterization.
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Experience with automation, commissioning, qualification, or operations in a cGMP environment. Proficient/ thorough knowledge of validation of principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory agency expectation and industry trends.
$120,000 - $160,000 a yearFull-timeExpandApply NowActive JobUpdated Today
cgmp quality jobs in Los Angeles, CA
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