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The Sr. Manager will be responsible for leading all facets of Technology Transfer into manufacturing, GMP floor support and Continued Process Verification in accordance with current good manufacturing processes (cGMP.
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Solid understanding of CMC manufacturing and analytical activities required in biotech/drug/vaccine development, including knowledge of cGMP regulations. Working knowledge of Veeva and Smartsheet a plus.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
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They will be responsible for all aspects of CMC strategy, process - analytical development and cGMP manufacturing. Evaluates and leads the selection of CDMOs to support the process analytical development and cGMP manufacturing of multiple small molecule product candidates.
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Ensuring Robust Production: Lead cell therapy manufacturing operations and facility support activities to ensure robust and safe production in compliance with cGMP requirements. Strong knowledge/ understanding of FDA regulations (GMP’s), industry standards, and cGMP Quality systems.
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Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must. Completes all documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP.
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Strong knowledge and understanding of cGMP, FDA, and other regulatory requirements for pharmaceutical manufacturing. Plan, direct, and coordinate the manufacturing activities of solid oral dosage tablet products, ensuring compliance with cGMP, FDA, and other regulatory requirements.
$140Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Work in compliance to AV Procedures and cGMP guidelines. As an Incoming Quality Assurance (IQA) Inspector, you will be responsible for the visual and dimensional inspection of incoming components/materials (i.e., injection molded plastics, thermoformed plastics, metals, machined components, extrusions, and metal tubing), information for use (IFUs), packaging, and labeling materials.
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Maintain inspection documentation in accordance with SOPs, WIs and GMP (CFRs) Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
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Expertise in cGMP and CAPA documentation. Knowledge of Process improvement tools and methodologies (Lean, Six Sigma) is preferred. Green or Black Belt Certification in Lean or Six Sigma is a plus.
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Participate in laboratory clean-up and ensure adherence to cGMP, GLP, and safety policies and procedures. Perform high purity water testing with guidance or support. Participate in laboratory clean-up and ensure adherence to cGMP, GLP, and safety policies and procedures.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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3+ years in a ISO/cGMP production environment. This position reports to the Chips Manufacturing Manager. Participate on project teams for new products as well as investigations and CAPA. At PacBio, we’re all on a mission to enable the promise of genomics to better human health.
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Good understanding of basic ISO13485 / FDA’s QSR/cGMP requirements. Good understanding of basic ISO13485 / FDA’s QSR/cGMP requirements. We are the maker of the Zephyr Endobronchial Valve and a global leader in interventional pulmonology, planning tools, and treatments for obstructive lung disease.
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Provide analytical support to the Quality Control function for routine and non-routine analysis. Read SOPs (Standard Operating Procedures) and excerpts from technical documentation. Prepare basic chemical solutions.
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Responsible for participating in continuous training: cGMP training, technical skills, safety, performance improvement. Review change to cGMP documentation and re-train. Responsible for participating in continuous training: cGMP training, technical skills, safety, performance improvement.
$17.7 - $21 an hourPart-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Knowledge of cGMP Quality Systems including change control, discrepancy management, CAPA, lot release and validation. cGMP Cell Culture or Purification experience required. Manage and oversee cGMP operations at Adverum’s drug substance CMO to ensure manufacture of Adverum products on-time and meeting quality, compliance, and applicable regulatory requirements.
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