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A working understanding of food manufacturing acronyms (SQF, HACCP, SOP, 5S, GMP) Provide day-off relief for the following positions: Cutter Operator, Curd Unloader, Cooker Operator and Table Assistant.
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Under the supervision of the Director of the Human Gene and Cell Therapy Facility (HGCTF), the HGCTF Lead Manufacturing Associate is responsible for the manufacturing of human gene and cell therapy products under Good Manufacturing Practices (GMP), quality control testing of these products to ensure that the products meet the required quality, supervise other manufacturing associates and overall management of all projects.
$6,566.67 - $14,583.33 a monthFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Description Under the supervision of the Director of the Human Gene and Cell Therapy Facility (HGCTF), the HGCTF Lead Manufacturing Associate is responsible for the manufacturing of human gene and cell therapy products under Good Manufacturing Practices (GMP), quality control testing of these products to ensure that the products meet the required quality, supervise other manufacturing associates and overall management of all projects.
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Perform hands on work in an adherent cell stack factories or suspension culture, cell culture expansion, viral vector production as well as process scale up and implementation into GMP clinical production suites.
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HemaCares vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization with high-quality RUO and GMP-compliant starting material and apheresis collections.
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Thorough understanding and working experience of pharmaceutical drug products concerning GMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements. Pharmaceutical Development, late-phase drug development, CMC, small molecule, GMP, ICH, FDA, EMA, New Drug Application.
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Works cross functionally and in close collaboration with R&D and MSAT teams for refining product characteristics and process operations in GMP and non-GMP settings. Works cross-functionally to drive innovation for T-cell production in a GMP setting.
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Experience in PET manufacturing, pharmaceutical manufacturing (FDA and GMP regulated), nuclear pharmacy, chemistry training or comparable laboratory background preferred. Documents, investigates and reviews any out of specification (OOS) or deviations as part of GMP compliance as it relates to engineering tasks.
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This may include functions of receiving, picking, packing, staging, and shipping required to support and maintain the integrity of the materials management and equipment maintenance system and functions within GMP and non-GMP environments.
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Must have familiarity with Good Manufacturing Practices (GMP) Preferred: Familiarity with ISO, IEC, and other standards pertaining to the medical device industry. In your inaugural year at Illuminant, you'll collaborate closely with the Hardware Lead, utilizing state-of-the-art industrial equipment, including multi-axis CNCs, wire EDM machines, and 3D printers.
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Food security, HACCP, GMP, SQF, Environmenmtal);Performs other duties as assigned. We produce a wide range of products including yeast extracts, inactive yeasts and their derivatives for flavour enhancers, enriched mineral and vitamin yeasts for the health supplement and health food markets, and high-grade yeast extracts for the biotech industry.
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Working with the firm’s management, in particular the Global Managing Partner (GMP), Regional Managing Partners (RMP), the Chief Operating Officer (COO) and other key stakeholders, the Global DS&E will identify, develop and implement initiatives at the core of the strategic development of the firm.
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Manufacturing GMP-grade cellular and gene therapy products, following established processes, SOPs, and master batch manufacturing records (includes processing blood, bone marrow, and other cell samples, isolating specific cell populations, preserving samples, and distributing them to appropriate testing laboratories.
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Qualifications : - Previous experience as a Food Safety Coordinator or similar role - Knowledge of OSHA, HACCP, SQF regulations and requirements - Strong attention to detail and organizational skills - Excellent communication and interpersonal skills - Ability to train and educate employees on safety protocols - Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) - Ability to work independently and as part of a team.
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Conduct laboratory work and associated record keeping in a safe manner and in keeping with generally recognized GLP, GMP and company & customer’s SOP. Perform analytical tests on Bulk, finished products, stability samples, raw materials, and other contract manufactured material in compliance with GMP and as directed by the QC Specifications.
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haccp gmp jobs in Los Angeles, CA
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