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Issues reports and documentation in accordance with established procedures on a variety of quality system programs related to QSR (CGMP) and ISO requirements. + Completes and reviews documentation in accordance with established procedures and quality system requirements (CGMP, ISO.
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Performs document control functions to ensure the integrity of all Stability and QC Laboratory records in accordance with cGMP requirements. Minimum of 1-year hands-on experience supporting cGMP manufacturing environment.
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Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP) Prefer experience with lean methods (e.g. "six sigma", TPM, etc.
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Knowledge of clean room protocols, drug discovery, process development, cell culture technologies and cGMP environments would be advantageous. Knowledge of clean room protocols, drug discovery, process development, cell culture technologies and cGMP environments would be advantageous.
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Description:The Packaging Operator III is responsible for safely operating the packaging equipment to package in process products in accordance with packaging orders, while following SOPs and Maintaining 100% cGMP & compliance during operations.
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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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Demonstrated mechanical and technical knowledge of cGMP and pharmaceutical packaging standard operating procedures. Demonstrated mechanical and technical knowledge of cGMP and pharmaceutical packaging standard operating procedures.
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Document all testing activities in accordance with cGMP.Performs duties according to LSS Global direction and in compliance with cGMP and GLP regulations and SGS Integrity programs. Job DescriptionThe Chemist I, Extractable & Leachable will perform material extractions, standard solution, and sample preparations to support GC-MS/FID and/or LC-MS/PDA and/or ICP-MS/OES analysis on extractable and leachable (E&L) testing of pharmaceutical containers and medical devices.
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6+ years of experience in a cGMP laboratory or commercial manufacturing setting (with a Bachelor's degree) or 4+ years (with a Master's degree). Ensure adherence to cGMP, FDA, and IVDR regulations.
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Ensure compliance with HSE, Quality policies, cGMP requirements, and defined procedures. Certified Global Meeting Planner. Ensure compliance with HSE, Quality policies, cGMP requirements, and defined procedures.
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Learn, understand and apply thorough quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP) Knowledge of World Class manufacturing methods (QLP, Lean, Six Sigma), Good Manufacturing Practices, Food Drug and Administration guidelines and process validation.
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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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Manufacturing cGMP production activities include solution preparation, master/working cell bank production, upstream cell culture, downstream protein purification, mRNA and molecular therapeutics production, and small-scale fill/finish.
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The Senior Quality Assurance Specialist (Engineer) ensures compliant manufacturing procedures, equipment, and facilities in our new manufacturing facility in adherence with cGMP requirements, Quality Standards, and other regulatory requirements.
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This position will develop and review protocols for new and existing cGMP systems, including manufacturing equipment, laboratory instrumentation, and processes, across our network of manufacturing facilities.
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