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Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.
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Experience within cGMP/FDA regulated industry. Basic understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique. Production of blood component lots through cell culture, harvest, and cryopreservation.
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The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and Client SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.
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O Lead the technology transfer process for client-derived advanced therapies, ensuring a smooth transition from development to cGMP manufacturing. We are seeking a highly motivated and experienced Associate Director, Manufacturing, to join an exciting Biotechnology company.
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Perform quality assurance support of manufacturing, laboratory and warehouse areas to ensure compliance with cGMP requirements and company procedures. Review of documentation supporting batch, warehouse, metrology, engineering and validation activities to ensure they are complete and in compliance with company policies and procedures, and cGMP requirements.
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Job Summary: This long-term career opportunity is with a nation-wide pharmaceutical manufacturer located in Chicago, IL. In this role, you'll use aseptic techniques to prepare solutions and operate pharmaceutical manufacturing equipment in a cGMP environment.
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The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and Catalent SOP) through document review/approval and real time monitoring/approval of manufacturing activities.
$35 an hourExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Coordinate and perform cGMP manufacturing operations for manufacturing biopharmaceutical products. Coordinate and perform cGMP manufacturing operations for manufacturing biopharmaceutical products.
$26.44 - $33.65 an hourFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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And apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP) The Production Associate, One year of manufacturing experience, preferred.
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Biology, mammalian cell, cell culture, aseptic technique, cryopreservation, thawing, gowning up, gmp, cgmp, upstream, downstream, mammalian, gene therapy. Responsible for manufacturing of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs.
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Monitor production manufacturing areas for compliance with SOP, cGMP, and safety requirements. Collect in-process and finished product samples during manufacturing and packaging as per the batch record and protocol.
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Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP) Notify the supervisor and take appropriate action if any safety, quality, mechanical or discrepancy issues occur Sustain a clean and safe work area using 6S principles What you’ll bring: Must be at least 18 years of age Must have basic English written and oral communication skills adequate to communicate with other team members.
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This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process.
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Key RequirementsHigh School Diploma or Equivalent minimum; AS/BS preferred in relevant STEM fieldPreferred area of study: Science related disciplineWorking experience within pharmaceuticals, life science, or biotech manufacturing; cGMP setting preferred, and/or some experience as an Associate Level I or level 2 in bio-pharma industry.
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Create and execute project plans for process and assay development and support the transfer of processes to cGMP manufacturing and quality control. As the Associate Director of Process Development, the individual will be responsible for creating protocols and methods for the production of various cell and gene therapy products, procuring the necessary equipment and components for cGMP production, making adjustments to the process and reagents to meet cGMP requirements, facilitating technology transfers, and developing assays for product characterization.
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