Quality Control Associate

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• Independently execute and review routine in-process, drug substance, and stability test methods in a timely manner.
• Use a variety of laboratory instrumentation and computer systems to collect and record data (such as LIMS, Charles River Endoscan, MODA).
• Maintain lab operations (including cleaning, ordering of supplies, reagent preparation, stocking, waste disposal).
• Conduct test methods including samples generated for facility monitoring (i.e., Environmental Monitoring and Critical Utilities), in-process, drug substance, and stability.
• Own and author quality system events (i.e., laboratory investigations, deviations, CAPA's and change controls).
• Demonstrate a functional and basic theoretical understanding of laboratory operations and Standard Operating Procedures (SOP's).
• Work within laboratory environment for extended periods of time, conducting facility monitoring (i.e., Environmental Monitoring and Critical Utility Monitoring) and product tests, reviewing data, maintaining laboratory materials and instruments and other laboratory functions as required.
• Complete all testing, including special project and protocol testing in a timely and appropriate manner.
• Maintain data integrity and ensure compliance with company SOP's, specifications, and cGMP regulations.
• Independently exercise judgment within generally defined Quality Control (QC) procedures and practices in selecting methods and techniques to troubleshoot problems and/or formulate solutions.
• Decisions have moderate impact on future QC processes and procedures that impact batch disposition.