Takeda
Manufacturing Investigation, Principal Analyst
Takeda, Round Lake Beach, Illinois, United States
Manufacturing Investigation, Principal Analyst
Join to apply for the Manufacturing Investigation, Principal Analyst role at Takeda Base pay range $99,500.00/yr - $156,420.00/yr 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. About The Role
The Manufacturing Investigation, Principal Analyst, is responsible for addressing and expediting product deviations within the company’s quality management system. This role ensures compliance with regulatory agencies and optimizes deviation management to prevent recurring events. By maintaining unified product defect investigation procedures, the Principal Analyst contributes to the continuous improvement of manufacturing processes. Additionally, the Manufacturing Investigation Principal Analyst will lead L1 Change Controls to implement process changes and improvements. The incumbent provides technical support to manufacturing functions including filling, inspection, and packaging operations. By maintaining high-quality standards, this role supports Takeda’s mission to deliver better health to people and a brighter future to the world. 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 reoccurring 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 Lead L1 Change Controls to implement process changes and improvements Support problem solving sessions using appropriate tools to coordinate and/or lead investigation teams 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 the department strategy What you bring to Takeda
Typically requires a bachelor’s degree in science, engineering or related technical fields and 5+ years of related experience; some leadership experience preferred Applies advanced investigation techniques independently, capable of analyzing complex situations and implementing solutions Identifies and implements corrective measures in CAPA processes Conducts root cause analysis with minimal guidance Understands and applies Good Manufacturing Practices independently Executes Quality Assurance tasks independently in routine and complex situations Conducts audits with understanding of principles in complex scenarios Produces clear and concise documentation Ensures safety concepts are applied independently Applies quality control principles independently Demonstrates practical biotechnology experience and independent task execution Applies process improvement techniques independently Communicates clearly and confidently in verbal form Important Considerations
Work in a controlled environment requiring gowning and protective clothing Remove all make-up, jewelry, contact lenses, nail polish and artificial nails while in the manufacturing environment Work in a cold, wet environment and may rotate 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 employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or other protected characteristics where required by law. Locations
USA - IL - Round Lake - Drug Delivery Worker Type
Employee Time Type
Full time Job Exempt
Yes
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Join to apply for the Manufacturing Investigation, Principal Analyst role at Takeda Base pay range $99,500.00/yr - $156,420.00/yr 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. About The Role
The Manufacturing Investigation, Principal Analyst, is responsible for addressing and expediting product deviations within the company’s quality management system. This role ensures compliance with regulatory agencies and optimizes deviation management to prevent recurring events. By maintaining unified product defect investigation procedures, the Principal Analyst contributes to the continuous improvement of manufacturing processes. Additionally, the Manufacturing Investigation Principal Analyst will lead L1 Change Controls to implement process changes and improvements. The incumbent provides technical support to manufacturing functions including filling, inspection, and packaging operations. By maintaining high-quality standards, this role supports Takeda’s mission to deliver better health to people and a brighter future to the world. 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 reoccurring 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 Lead L1 Change Controls to implement process changes and improvements Support problem solving sessions using appropriate tools to coordinate and/or lead investigation teams 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 the department strategy What you bring to Takeda
Typically requires a bachelor’s degree in science, engineering or related technical fields and 5+ years of related experience; some leadership experience preferred Applies advanced investigation techniques independently, capable of analyzing complex situations and implementing solutions Identifies and implements corrective measures in CAPA processes Conducts root cause analysis with minimal guidance Understands and applies Good Manufacturing Practices independently Executes Quality Assurance tasks independently in routine and complex situations Conducts audits with understanding of principles in complex scenarios Produces clear and concise documentation Ensures safety concepts are applied independently Applies quality control principles independently Demonstrates practical biotechnology experience and independent task execution Applies process improvement techniques independently Communicates clearly and confidently in verbal form Important Considerations
Work in a controlled environment requiring gowning and protective clothing Remove all make-up, jewelry, contact lenses, nail polish and artificial nails while in the manufacturing environment Work in a cold, wet environment and may rotate 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 employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or other protected characteristics where required by law. Locations
USA - IL - Round Lake - Drug Delivery Worker Type
Employee Time Type
Full time Job Exempt
Yes
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