Sr Quality Control Technician I

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the Role: As a Sr Quality Control Technician I , you will play an important role in supporting Quality Control Microbiology operations that help ensure the safety, quality, and compliance of Takeda's pharmaceutical products. You'll perform a variety of biological, chemical, and physical analyses throughout the manufacturing process, from incoming raw materials through in-process materials and finished products. In this hands-on role, you'll support environmental monitoring, critical utility sampling and testing, endotoxin and bioburden testing, and microbial identification while utilizing laboratory instrumentation and computerized systems such as LIMS to accurately collect, document, and manage data. You'll work closely with Manufacturing, Quality Assurance, Engineering, Maintenance, and other site functions to support production activities and maintain a strong culture of quality and compliance. Your attention to detail, technical skills, and commitment to data integrity will help ensure that Takeda's products meet rigorous quality standards and ultimately reach patients safely. How You Will Contribute: Perform environmental monitoring and critical utility sampling and testing to evaluate manufacturing environments and critical utility integrity. Conduct biological, chemical, and physical analyses on raw materials, in-process samples, and final products, including endotoxin, bioburden, and microbial identification testing. Perform laboratory assays requiring accurate analytical techniques and application of fundamental biology and chemistry principles, completing routine and special project/protocol testing accurately and within established timelines. Operate laboratory instrumentation and computerized systems, including LIMS, to collect, record, reconcile, and maintain accurate laboratory data and documentation. Maintain data integrity and ensure laboratory activities comply with applicable SOPs, specifications, FDA, GLP, QSR, and cGMP requirements. Maintain laboratory supplies and inventory necessary to support routine testing and perform document requests, archival, and reconciliation activities as needed. Apply continuous improvement practices, including QLP, 5S, LEAN, Standard Work, housekeeping, and GEMBA walks, to support laboratory efficiency and operational excellence. Troubleshoot routine laboratory and testing issues, identify when established practices or procedures are not being followed, and escalate issues appropriately. Collaborate with Manufacturing, Quality Assurance, Engineering, Maintenance, and other support functions to coordinate testing activities, communicate results, and support site operations. Follow all laboratory and site safety requirements, complete assigned training on time, and support additional business needs and projects as assigned. What You Bring to Takeda: Bachelor's degree in Chemistry, Biological Science, or another related scientific or technical field required; relevant laboratory work experience preferred. Foundational laboratory skills and knowledge of basic microbiology, chemistry, and statistical methods required. Experience with laboratory testing and analytical techniques, including environmental monitoring, critical utility sampling, endotoxin, bioburden, or microbial identification preferred. Knowledge of laboratory equipment and instrumentation, including autoclaves, incubators, and analytical equipment, with the ability to operate equipment in accordance with established procedures required. Strong technical problem-solving skills and the ability to recognize when established practices, procedures, or expected results are not being followed required. Ability to manage multiple tasks concurrently, prioritize activities, and complete testing and documentation accurately and within established timelines required. Ability to read, understand, and follow detailed written procedures and instructions, including SOPs and laboratory methods required. Strong verbal and written communication skills, with the ability to effectively communicate with supervisors, peers, and cross-functional partners required. Proficiency with mathematical calculations and the ability to work with both metric and U.S. measurement standards required. Basic knowledge of chemical and biological safety procedures and demonstrated commitment to maintaining a safe laboratory environment required. Good computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint; experience with LIMS or other laboratory information systems preferred. Demonstrated ability to train or assist in training other team members and contribute effectively to interdepartmental teams preferred. Important Considerations: At Takeda, our patients rely on us to deliver safe, high-quality products. As a result, we follow strict quality, safety, and compliance requirements throughout our manufacturing and laboratory operations. In this role, you may: Lift, push, pull, and carry up to approximately 25 lbs. Work in controlled environments requiring special gowning and protective clothing over the head, face, hands, feet, and body; additional hearing protection may be required in loud areas. Perform a combination of sedentary work, standing, and walking throughout the facility. Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection. Work or be assigned to a different shift to meet business needs, including weekends and swing shifts, and must be willing to work off-shift hours. Work supplemental hours as necessary to complete work commitments. Work in confined areas. Work primarily indoors, including areas with clean room and cool/hot storage conditions. Follow all applicable site and laboratory safety rules, GMP requirements, SOPs, and quality procedures. Speak, read, write, and follow detailed written and oral instructions in English. Complete all required training within established timelines. <