Quality Control Analyst II
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About The Position
Takeda Manufacturing U.S.A., Inc. is seeking a Quality Control Analyst II with the following duties: Perform supportive activities for general lab readiness, laboratory equipment qualification and method transfers; conduct critical biological test methods (Endotoxin, Bioburden, Environmental Monitoring, pharmaceutical water systems, aseptic technique) including samples generated for in-process, drug substance and stability; use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS); initiate and own deviations, CAPAs and change controls within the electronic Quality Management System; exercise judgment within generally defined Quality Control procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate solutions; provide training to new QC Analysts on routine procedures and practices; complete all testing, including special project/protocol testing; maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations; draft studies and investigations of moderate scope and works on problems in which the analysis of the situation or data requires a review of identifiable factors; author new SOPs and initiates changes to existing procedures.
