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Maintain a current knowledge of applicable phase appropriate FDA and International cGMP regulations for Regenerative Medicine, Cell Therapy, and Good Tissue Practices. In addition to conducting activities that ensure the biologics manufacture and facility is compliant with applicable regulations, policies, procedures and expectations of phase appropriate current Good Manufacturing Practices (cGMP.
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Learn and maintain thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures.
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Ensure that packaging’s complies with hazardous materials transportation, FDA, EPA, cGMP, and ISO regulations and guidelines. Ensure compliance with applicable requirements for domestic and international multi-modal safe transport of listed hazardous materials products including the United States Department of Transportation (DOT), International Air Transport Association (IATA), International Maritime Dangerous Goods (IMDG), and United Nations (UN.
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Direct key personnel in donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedures, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice (cGMP.
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Ensure all calibration and thermal mapping activities comply with relevant industry regulations (e.g., FDA, cGMP). Strong understanding of regulatory requirements (FDA, cGMP, CFR part 210/211, CFR part 820, etc.
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Preferred:Good understanding and exposure to current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirementsThorough understanding of and experience with some aspect of technical operations; interest and demonstrated ability to learn across several disciplines (manufacturing, quality, supply chain, technical development, regulatory, patient experience, finance, operations, etc.
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Supervise donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP.
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Support bioprocessing activities (buffer preparation, upstream, downstream, aseptic fill) in a cGMP cleanroom setting. Krystal received U.S. FDA approval for the first-ever redosable gene therapy treatment, VYJUVEK, for the treatment of Dystrophic Epidermolysis Bullosa.
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Expert in Design Controls and compliance to FDA, cGMP, ISO, ASTM, MDD, and MDR requirements. Hyperfine (NASDAQ: HYPR) is the groundbreaking MedTech company that created Swoop, the world's first FDcleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care.
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The GMP Microbiology Lab Analyst will perform microbiological assays, related to bioburden testing, utility monitoring, raw material, and finished product testing in accordance with cGMP/FDA regulations as they apply to the pharmaceutical industry.
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Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc. The role of a Manufacturing Technician is to perform all tasks associated with formulation, preparation, assembling, and packaging of components, according to cGMP Guidelines to meet production demands.
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Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations. A high level of aptitude for cGMP biopharmaceutical manufacturing processes (upstream/downstream), including process knowledge of UF/DF Systems, Chromatography, Bioreactors, Seed Train, Disposable Technologies (SUMs, SUBs), Clean-in-Place (CIP), and Steam-in-Place (SIP.
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Prior experience with CMC regulatory activities and/or agency (FDA) interactions in the development of advanced biologics. The QA Specialist is responsible for all aspects of Quality Assurance related to internal processes and manufacturing activities that will take place within the DFI cGMP Facility.
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Audits the fresh DF in accordance with FDA cGMP guidelines, the DF Food Safety Plan as it pertains to the Preventive Control Rule, and the DF Seafood HACCP plan, with oversight of the QA Supervisor.
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Ensure that production personnel follows compliance of all Center activities with cGMP, Kedplasma DCOP's (Donor Center Operating Procedures) and other Company standards and protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required.
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