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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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Knowledge of FDA regulations for the cGMP of Dietary Supplements and Foods. Ensures accurate and timely completion of all tasks relating to Batch records and maintenance of cGMP and SOP records.
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Assists in qualification of cGMP facilities and analytical instrumentation in the Center for Molecular Imaging (CMI). Assists researchers in Institutional Research Board (IRB) and Food and Drug Administration (FDA) submissions and coordinates with clinical partners across the Texas Medical Center (TMC.
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Job Overview: A law firm in Washington, D.C., is seeking an FDA - Health Care Associate Attorney with 4-6 years of experience and a strong background in drug and medical device regulatory compliance issues, particularly in current good manufacturing practice (CGMP) matters.
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Our R&D Quality Control team seeks a talented Senior QC Analytical Chemist to join an innovative organization to serve as Cresilon's Subject Matter Expert (SME) and technical leader in cGMP Analytical Chemistry.
$110,000 - $135,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Maintains compliance with FDA Regulations and other industry accepted standards. Supports and participates in audit preparations and inspections by certifying agencies and regulatory bodies, i.e. USP & FDA. Participate in developing action plans and executing corrective actions in a timely manner.
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Strong understanding of regulatory requirements and guidelines for cell and gene therapy manufacturing (e.g., cGMP, FDA regulations). Ensure compliance with regulatory standards (e.g., FDA, EMA, ICH) and industry best practices for cell and gene therapy manufacturing.
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Maintain data integrity and ensure compliance with company SOP's and specifications, FDA, GLP. CSR and cGMP regulations investigate deviations and write exception documents. Will understand and apply cGMP/GDP, follow CTP/SOPs, and meet EHS requirements.
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The Senior QA Associate, Compliance/QA Lead will be responsible for identifying, closing, and implementing corrective actions regarding gaps in current good manufacturing practices (cGMP) related activities to comply with FDA regulations, support Serialization and aggregation process implementation for Granules Consumer Health.
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Proven track record with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP, and QMS standards. Experience with metal stamping, laser cutting and chemical etching.
$125,000 - $140,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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The Company Scorpius BioManufacturing is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. Key Responsibilities Assist in the development and optimization of upstream biologics (mammalian and bacterial)/cell therapy production processes that follow FDA and/or appropriate global regulations and guidelines.
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Supervise the day-to-day technical operations and quality of the R&D Chemistry laboratory in a high-growth, fast-paced, dynamic work environment while ensuring compliance with FDA cGMP/GLP and DEA regulations.
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Prior experience with CMC regulatory activities and/or agency (FDA) interactions in the development of advanced biologics is a plus. The Bio-Processing Engineer is responsible for all aspects of microbiome drug substance process development that will take place within the DFI cGMP Facility.
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Gmp, blender, mixer, food safety, cgmp, mix, batch, blend, fda, haccp, sqf, brc, gfsi, Fermentation, Compounding, Mixing, Blending, Dairy, blending, mixing, food production, food manufacturing.
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An understanding of Quality Control and Quality Assurance cGMP requirements in FDA regulated environments preferred. Ensure finished products meet labeling standards for hemp including compliance with FDA regulations for foods and dietary supplements, ingredients, limitations on health claims, disclaimers and warnings.
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