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The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers' manufacturing workflows - regardless of batch size.
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Relevant experience in good laboratory/manufacturing practices (GLP/cGMP), laboratory quality control or stability, and interaction with quality assurance is required. Must be able to communicate effectively with manufacturing and quality personnel.
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Knowledge of cGMP for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis, knowledge in reliability engineering (including asset life cycle management.
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Team Development: Build and lead an empowered team of quality and regulatory experts, overseeing tools, business processes, and procedures supporting cell-based bioassay, cell & gene therapy, and virology testing.
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In this critical role you will p erform laboratory work in a cGMP manufacturing setting, primarily working with iPSC cell culture and differentiation, following bio-manufacturing procedures and manufacturing schedules to facilitate on-time delivery of high-quality finished products.
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This key individual will provide support involving product design and development, product testing and disposition, quality investigations and cGMP oversight to product manufacturing, evaluation, and release.
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Extensive knowledge of Dietary Supplements CGMP activities and Quality Systems. An established company in Northeast Florida specializing in Confectionery and Dietary Supplements is seeking an experienced Quality Director for an immediate opening.
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Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed. Has a basic understanding of cGMP and quality systems. Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol.
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Support Hoxworth Blood Center’s safety, cGMP, and Quality Plan in coordination with the Division Director, Quality and Regulatory Affairs. HBC is recruiting for Manager, Biomedical Engineering, to manage the daily operations of the Biomedical Specialist team, and ensure strict compliance with product quality assurance, equipment and procedural standards, health and safety protocols.
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Is a boutique biologics CDMO providing cGMP manufacturing, bioanalytical, and process development services for protein modalities. The Microbiology Manager is also responsible for the development, implementation, and compliance of activities in the microbiology laboratory area to meet production goals, quality, and cost objectives.
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3+ years of quality experience in the food industry; knowledge and proven experience with food safety programs and systems: GFSI (BRC or SQF preferred), internal auditing, cGMPs, HACCP, FSMA. Participate in training programs as needed (e.g., BRC/SQF, cGMP, HACCP, Safety.
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Perform hands-on laboratory testing utilizing various analytical techniques including ddPCR, flow cytometry, cell counting, and cytotoxicity assays in support of cGMP clinical manufacturing. In this role, you will perform and evaluate the analytical quality control testing studies to support assay characterization and qualification and Phase 1 manufacturing for cell therapy - collaborating with internal partners and external CMOs / CROs.
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Routinely provide performance feedback and guidance to employees in addition to conducting formal evaluations and reviews QUALIFICATIONS BS or MS in analytical chemistry, biochemistry, or biotechnology or equivalence BS with 3+ years or MS (0+ years) of professional experience in the vaccine or pharmaceutical industry in the field of QC analytics or R&D. Preferred 2 years of experience in cGLP or cGMP lab.
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Represent Manufacturing Science and Technology on project teams and works closely with Quality Assurance (QA), Global Procurement, Supply Chain, Supply Relationship Manager (SRM), Product Development (PD) and project team members in developing strategies and problem-solving efforts.
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Perform job duties within the established quality control guidelines of the Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP). CORE COMPETENCIES: PACKAGING TECHNICIAN I (0-24 Month Period) Must be proficient in two Packaging Zones (Zone 4 1 other) Review and begin building knowledge of required SOP and cGMP guidelines for position.
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