Sterility Assurance, Senior Analyst

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The Sterility Assurance, Senior Analyst ensures the quality of processes and product outputs by defining activities, processes, and standards to meet quality requirements. This role involves auditing, monitoring, and determining the quality of processes or outputs against defined internal and regulatory standards, contributing to Takeda's mission of delivering high-quality products. The incumbent will provide quality oversight of the laboratory and manufacturing operations in addition to implementing and maintaining an effective quality control program in alignment with internal company standards and current industry practices.

This employee will typically focus on disciplines related to environmental monitoring, laboratory methods, contamination control strategies, and pharmaceutical microbiology.

• Owns Standard Operating Procedures and other Quality Documentation relevant to Quality Control and Sterility Assurance department. Approves Standard Operating Procedures and other Quality Documentation pertinent to all areas of the plant.

• Develops and delivers training materials relevant to Quality operations. Approves training materials pertinent to all areas of the plant.

• Owns investigations and CAPAs relevant to Quality Control and Sterility Assurance function.

• Review and approve documents following cGMP guidelines.

• Performing data trending and analysis to identify quality shifts, detect potential nonconformances, and support proactive decision‑making to maintain product and process integrity.

• Participate in internal and external regulatory audits as a SME for Quality Control and Sterility Assurance and present to auditor, if required.

• Proactively identifies, escalates, and/or resolves potential contamination risk and/or negative trends in quality control data.

• Exercises judgment for broadly defined practices, procedures, and policies to select methods, techniques, and evaluation criterion.

• Forward thinking ensures decisions do not negatively impact future Quality processes and procedures and other departments within the organization.

• Uses judgment and experience to troubleshoot problems and formulate solutions.

• Coaches and mentors manufacturing personnel on the floor on aseptic awareness and appropriate cleanroom behaviors.

• Drive continuous improvement initiatives by analyzing current processes, identifying efficiency opportunities, and implementing optimized workflows, including the digitalization and automation of paper‑based forms to enhance accuracy, speed, and overall operational performance.

• Typically requires bachelors' degree in science, engineering, or other related technical field. 3+ years of related work experience. Bachelor's Degree in Chemistry or Biological Science is preferred.

• Experience in Environmental Monitoring, Bioburden, and Sterility testing data trending.

• Experience in method transfer as well as knowledge of equipment and instrument qualification/validation.

• Experience in implementation and use of electronic laboratory management systems.

• Must have knowledge of FDA Regulations, Application of Good Manufacturing Practice, and Good Laboratory Practices.

• Comprehensive knowledge of aseptic processing of biologic solutions, sterile filtration, Moist Heat sterilization, and Hydrogen Peroxide decontamination processes.

• Must have working knowledge of current quality control laboratory principles such as Environmental Monitoring, disinfectant efficacy, and Environmental Monitoring Performance Qualification (EMPQ).

• Must demonstrate strong leadership, influence, and cross-functional collaboration skills and able to work efficiently in a cross-functional team environment.

• Skilled in use of electronic word processing, spreadsheet, project management, and presentation tools such as…