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The QA Associate works closely with QA operational and compliance teams in a support function to ensure compliance to relevant SOPs and cGMP standards. Retrieval and control of quality / cGMP documentation.
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Learn and maintain thorough familiarity and compliance with all state and federal regulations, 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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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.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
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Performs manual aspects of the operation process, including but not limited to making boxes, loading machines, hand packing product, visual and physical checks of in process and finished materials as trained and instructed by supervisor, in compliance with all safety and cGMP procedures.
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Creates, updates, reviews, maintains and archives records and other key documents to provide track and trace evidence for every aspect of the secondary packaging and distribution of investigational product in a cGMP state.
$18 - $21.42 an hourExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Provide quality inspections on the floor, AQL sampling/inspection of in-process intermediates and finished products, and performing quality checks to ensure equipment and processes are in compliance to procedures, specifications, and cGMP requirements.
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Requirements and cGMP, Author validation protocols and technical reports (e.g., Pre Validation Studies, Performance Qualifications, Requalifications, Validation/Qualification of utilities (i.e. WFI, UPW, Process air), processing equipment, testing equipment, facilities.
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Ensure compliance with all appropriate company and regulated policies and procedures, batch records (cGMP, FDA, DEA, OSHA and other applicable regulations). All products manufactured by Dechra must be completed following appropriate procedures in a clean and safe work environment meeting all cGMP, FDA, DEA, OSHA and other applicable regulations.
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Ensures a safe workplace complies with established standards and procedures (e.g., cGMP and SOPs)Encourages growth and contributions by team members. including planning, directing, and monitoring production to meet established specifications, schedules, volume/cost/wastage targets, and quality standards; liaising with Manufacturing Engineering, Supply & Logistics, Sales, etc.
Full-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Of 2 years’ experience with each of the following: ISO13485 and cGMP; Process and Product development lifecycle; DOE, QSR, and IQ/OQ/PQ; PFMEA and PFMECA; SPC principles and Minitab; Microsoft Project; Lean and Six Sigma practices to include DMAIC process, root cause analysis, 5S, scrap reduction, and yield improvements; and CAPA.
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Responsible for training on all relevant SOPs and always maintain compliance with related SOPs and current Good Manufacturing Practices (cGMP) in the manufacturing process. The operator must follow detailed batch instructions which includes precisely weighing and adding raw materials as part of making blending batches.
Full-timeExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Sanitizing fill suites and ancillary areas, per standards and procedures (cGMP, SOPs, etc. following cGMP (Current Good Manufacturing Practices and cGDP (Current Good Documentation Practices.
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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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Knowledge of cGMP requirements for life sciences projects. Strong understanding and knowledge of life sciences markets and processes (fermentation, cell / gene therapy, API, blood products, purification, fill / finish, medical devices, etc.
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Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Part brand ambassador, part clinical technician. Employee assistance program (EAP.
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cgmp job in Fort Worth, TX
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