TAKEDA PHARMACEUTICALS AMERICA, INC.
Manufacturing Investigation, Principal Analyst
TAKEDA PHARMACEUTICALS AMERICA, INC., Round Lake, Illinois, United States, 60073
Overview
Manufacturing Investigation, Principal Analyst at Takeda Pharmaceuticals America, Inc. Location: Round Lake Beach, Illinois. The role is responsible for addressing and expediting product deviations within the company's quality management system, ensuring regulatory compliance, and optimizing deviation management to prevent recurring events. The incumbent leads L1 Change Controls to implement process changes and improvements and provides technical support to manufacturing functions including filling, inspection, and packaging operations. How You Will Contribute
Investigate and respond to product deviations, ensuring compliance with quality management procedures Monitor and analyze trends in deviations to recommend corrective and preventive actions Maintain and update unified product defect investigation operating procedures Provide technical expertise to optimize deviation management and prevent recurring events Collaborate with internal and external stakeholders to ensure effective communication and resolution of issues Conduct and document investigations in a timely manner to support on-time closure of non-conformances to meet product fulfillment dates Lead L1 Change Controls to implement process changes and improvements Support problem solving sessions through application of problem-solving tools and methods to coordinate and/or lead investigation teams; lead routine and complex investigations Audit and monitor processes to ensure compliance with internal and regulatory standards Conduct product integrity testing, including coloring, fitting, pattern, and wet processing Mentor junior Lead Investigators and contribute to department strategy What You Bring To Takeda
Bachelor’s degree in science, engineering or related technical field and 5+ years of related experience; some leadership experience preferred Applies advanced investigation techniques independently, capable of analyzing complex situations and implementing solutions Identifies flaws in Corrective And Preventive Action processes and implements corrective measures effectively Conducts root cause analysis with minimal guidance in moderately complex situations Understands and applies Good Manufacturing Practices independently in various contexts Executes Quality Assurance tasks independently Performs audits with a comprehensive understanding in complex scenarios Demonstrates advanced writing skills for clear and concise documentation Ensures safety assurance independently and applies safety concepts effectively Applies quality control principles independently Demonstrates practical experience in biotechnology and understands biological processes Applies process improvement techniques independently Communicates clearly and confidently in various contexts Role Details
Job ID: R0163918 | Date posted: 09/30/2025 | Location: Round Lake Beach, IL Important Considerations
Work in a controlled environment requiring special gowning and protective clothing; may include hearing protection in loud areas Remove makeup, jewelry, contact lenses, nail polish and/or artificial nails while in the manufacturing environment Work in a cold, wet environment and may require shifts including weekends Work around chemicals that may require respiratory protection EEO Statement
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all applicants regardless of race, color, religion, sex, sexual orientation, gender identity, parental status, national origin, age, disability, citizenship status, genetic information or other protected characteristics, in accordance with applicable laws. Locations
USA - IL - Round Lake - Drug Delivery Worker Type
Employee |
Worker Sub-Type
Regular |
Time Type
Full time |
Job Exempt
Yes
#J-18808-Ljbffr
Manufacturing Investigation, Principal Analyst at Takeda Pharmaceuticals America, Inc. Location: Round Lake Beach, Illinois. The role is responsible for addressing and expediting product deviations within the company's quality management system, ensuring regulatory compliance, and optimizing deviation management to prevent recurring events. The incumbent leads L1 Change Controls to implement process changes and improvements and provides technical support to manufacturing functions including filling, inspection, and packaging operations. How You Will Contribute
Investigate and respond to product deviations, ensuring compliance with quality management procedures Monitor and analyze trends in deviations to recommend corrective and preventive actions Maintain and update unified product defect investigation operating procedures Provide technical expertise to optimize deviation management and prevent recurring events Collaborate with internal and external stakeholders to ensure effective communication and resolution of issues Conduct and document investigations in a timely manner to support on-time closure of non-conformances to meet product fulfillment dates Lead L1 Change Controls to implement process changes and improvements Support problem solving sessions through application of problem-solving tools and methods to coordinate and/or lead investigation teams; lead routine and complex investigations Audit and monitor processes to ensure compliance with internal and regulatory standards Conduct product integrity testing, including coloring, fitting, pattern, and wet processing Mentor junior Lead Investigators and contribute to department strategy What You Bring To Takeda
Bachelor’s degree in science, engineering or related technical field and 5+ years of related experience; some leadership experience preferred Applies advanced investigation techniques independently, capable of analyzing complex situations and implementing solutions Identifies flaws in Corrective And Preventive Action processes and implements corrective measures effectively Conducts root cause analysis with minimal guidance in moderately complex situations Understands and applies Good Manufacturing Practices independently in various contexts Executes Quality Assurance tasks independently Performs audits with a comprehensive understanding in complex scenarios Demonstrates advanced writing skills for clear and concise documentation Ensures safety assurance independently and applies safety concepts effectively Applies quality control principles independently Demonstrates practical experience in biotechnology and understands biological processes Applies process improvement techniques independently Communicates clearly and confidently in various contexts Role Details
Job ID: R0163918 | Date posted: 09/30/2025 | Location: Round Lake Beach, IL Important Considerations
Work in a controlled environment requiring special gowning and protective clothing; may include hearing protection in loud areas Remove makeup, jewelry, contact lenses, nail polish and/or artificial nails while in the manufacturing environment Work in a cold, wet environment and may require shifts including weekends Work around chemicals that may require respiratory protection EEO Statement
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all applicants regardless of race, color, religion, sex, sexual orientation, gender identity, parental status, national origin, age, disability, citizenship status, genetic information or other protected characteristics, in accordance with applicable laws. Locations
USA - IL - Round Lake - Drug Delivery Worker Type
Employee |
Worker Sub-Type
Regular |
Time Type
Full time |
Job Exempt
Yes
#J-18808-Ljbffr