Quality Control Analyst I
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About The Position
As a Quality Control Analyst I at Takeda Pharmaceutical, you will play a crucial role in ensuring the quality and compliance of our pharmaceutical products. Located in Brooklyn Park, MN, you will report directly to the Team Lead of Quality Control. Your primary responsibilities will include building routine in-process, drug substance, and stability test methods, utilizing a variety of laboratory instrumentation and computer systems to collect and record data. This includes systems such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower. You will also be responsible for maintaining lab operations, which encompasses cleaning, ordering supplies, reagent preparation, stocking, and waste disposal. In this role, you will demonstrate a functional understanding of laboratory settings and Standard Operating Procedures (SOPs). You will work within a laboratory environment for extended periods, conducting facility monitoring, product tests, reviewing data, and maintaining laboratory materials and instruments. Your contributions will include completing all testing, including special project and protocol testing, while ensuring data integrity and compliance with company SOPs, specifications, and cGMP regulations. You will support low-risk deviations, CAPAs, and change controls within the electronic Quality Management System, initiate and own laboratory investigations, and occasionally participate in department problem-solving. Additionally, you will be expected to author minor revisions to existing SOPs and receive general instructions on routine work and detailed instructions on new assignments.
