QC Specialist III - Microbiology

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Conduct advanced microbiological research and testing to support QC Micro projects. This role involves equipment qualification, partnership in the development of and validation of Microbiology methodologies, analyzing complex data, and ensuring compliance with regulatory standards. Self-led individual that works under only very general supervision to meet deadlines/goals.

• Identify and drive continuous improvement projects to improve quality, service, reliability, delivery, and/or cost by enhancing microbiological testing and laboratory operations.

• Lead and provide project support for QC Microbiology, including microbiological assay validation, laboratory equipment qualification, and method improvement studies.

• Understand operations/processes to provide technical support to troubleshoot and resolve issues related to microbiological assays, instruments, and equipment.

• Author technical documents, protocols, and reports related to lab equipment qualifications, assay validations, and compliance-related studies as needed.

• Maintain and compile QC Microbiology metrics including trend reports as needed (e.g., environmental monitoring).

• Perform or review gap assessments for QC Microbiology to align with Global standards and regulatory requirements.

• Maintain applicable QC Microbiology Standard Operating Procedures (SOP) to ensure compliance with FDA guidelines, QSR, cGMP, and other regulatory standards and drive procedural improvements.

• Support internal and external audits (e.g., FDA, Corporate Quality Assessments) by ensuring compliance with procedures, guidelines, and regulatory requirements.

• Serve as a subject matter expert and point of contact during inspections, providing responses to inquiries and demonstrating compliance with regulatory requirements.

• Provide technical training and presentations to QC laboratory staff, including management, to ensure understanding of microbiological testing procedures and compliance.

• Lead or actively contribute to team initiatives that enhance efficiency, cost savings, quality improvements, and problem-solving.

• Proactively identify training needs, ensure personal training requirements and meet, and maintain training records for laboratory personnel.

• Stay current in the technical and compliance fields related to lab instruments, microbiological methods, and industry best practices.

• May perform other duties as assigned.

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

• Strong knowledge of cGMP, QSR, USP, CFR, and other regulatory requirements.

• Demonstrated working knowledge of microbiological assays, instrumentation, and equipment.

• Ability to manage multiple priorities, meet deadlines, and maintain high-quality standards.

• Strong organizational and problem-solving skills, with the ability to recommend and implement technical solutions.

• Proficient in Microsoft Office (Word, Excel) and other relevant digital tools.

• Detail-oriented, accountable, and committed to quality and compliance.

• Skilled in decision-making to address technical, compliance, or operational issues; supports cross-functional problem-solving initiatives.

• Solid understanding of laboratory, manufacturing, and facility processes.

• Excellent verbal and written communication skills; able to collaborate effectively and train peers.

• Working knowledge of applicable SOPs, EHS requirements, and cGMP/GDP standards.

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a…