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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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Maintain compliance with SOP, current Good Manufacturing Procedures (cGMP) and regulatory guidelines. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide.
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Previous experience in a fast-paced cGMP environment is strongly preferred. bioMerieux is looking to add a Manufacturing Maintenance Technician I/II/III to our growing team! Finished Goods Manufacturing Maintenance Technician I, II or III - B Shift.
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Responsible for maintaining logs and records to support operation and maintenance of critical systems and ensure effective operation and cGMP compliance of all equipment and buildings. Responsible for working during scheduled plant shutdown days.
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Performs in vitro cell culture assays under cGMP conditions and demonstrates use of aseptic technique to perform in vitro cell culture and ex vivo expansion of tissue isolates. On-the-job training specific to cellular and therapeutic apheresis, hematopoetic progenitor cell and other types of cell processing using aseptic technique, flow cytometry and product preparation for infusions.
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Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements. Bachelor's Degree in Science or related field from an accredited college or university, and one (1) year pharmaceutical, medical device, nutraceutical, or food processing quality assurance experience.
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1-2 years of industry experience in a cGMP industrial molecular biology group, performing reagent manufacturing and quality control testing required; Familiarity with range of molecular biology techniques (qPCR, DNA extraction, DNA sequencing) and proficiency with molecular biology calculations (dilutions, DNA and protein concentration measurements, enzyme activity measurements); there will be a test.
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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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Ensures legal and regulatory compliance in respect of safety, cGMP and quality systems. We leverage our expertise in the science and technology of blending and formulating phosphate, mineral and botanical based ingredients for our customers.
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Maintain MFG and QA cGMP and ISO compliance. Familiarity with cGMP, FDA, and guidelines governing the manufacture and release of medical devices. The Quality Supervisor will supervise and coordinate the functional activities of QA non-exempt personnel, to oversee inspection, testing, disposition, and control of components, materials, subassemblies, final product, returned product, and documentation retention.
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Strongly prefer minimum of 3 years facility maintenance and/or construction experience in a manufacturing environment with preference in pharmaceutical, nutraceutical or food processing industries. Prefer experience and proficiency to secure Boiler Operator (High Pressure) certification and/or electrical licenses; prefer already licensed.
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Provide oversight and support of Quality Engineering Sustaining, Metrology operations including design and/or review, development, implementation, and maintenance of measurement programs, ensuring that all cGMP requirements are satisfied.
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Ensure compliance with SOPs, cGMP, and other quality/FDA regulatory requirements. Experience in quality management systems, cGMP/ISO preferred. Ensure compliance with SOPs, cGMP, and other quality/FDA regulatory requirements.
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2+ years cGMP. Bachelor's degree/4 year program with an emphasis on a biological science. Experience: Pipetting/liquid handling, technical writing/reviewing, cGMP, detail oriented work.
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Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
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cgmp job in Salt Lake City, UT
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