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Perform Quality Assurance tasks such as sampling, inspections, and tests designed to ensure manufactured products are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations. Document all work performed, ensuring accuracy and thoroughness. Inform management of any deviations from established standards/procedures.
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The Director, Clinical Pharmacology provides strategic scientific and technical leadership across all aspects of Clinical Pharmacology and model-informed drug development, including study strategy, pharmacokinetic (PK) and PK/PD analysis, modeling and simulation, and regulatory submissions to support early- and late-stage clinical development.
This role serves as a key cross-functional leader with regulatory affairs, clinical operations, clinical research project management, data management, biostatistics, and external partners to ensure clinical pharmacology strategies and deliverables are aligned with corporate objectives, regulatory expectations and internal standard operating...
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· The primary purpose of this position is to lead Quality Engineering (QE) activities for product and process support including Validation of Manufacturing Processes, Cleaning Processes, and Test Methods, Qualification of Equipment, Utilities, and Facilities, Risk Management, and Annual Product Reviews.
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Performs professional, technical laboratory functions.
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Perform Quality Control tasks such as sampling and inspections designed to ensure incoming materials/components are disposition in a timely manner and are in compliance with internal SOP’s, Safety initiatives, Company policies, FDA and DEA regulations. Document all work performed ensuring accuracy and thoroughness. Inform management of any quality issues, failures or deviations from established standards/procedures.
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The Mfg Operator BC performs all the general duties and operations to manufacture the product. An operator will operate machines and handle components using prescribed standard operating procedures and cGMP guidelines to manufacture and ensure the product meets the quality requirements. The operator will complete the necessary documentation and records to maintain quality control.
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Performs professional, technical laboratory functions