Takeda Pharmaceutical (US)
Manufacturing Investigation, Principal Analyst
Takeda Pharmaceutical (US), Round Lake Beach, Illinois, United States
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 the manufacturing functions which includes 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 Investigation in a timely manner to support the 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 the 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 the department strategy What you bring to Takeda:
Typically requires a bachelor’s degree in science, engineering or other 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. Independently identifies flaws in Corrective And Preventive Action processes and implements corrective measures effectively. Conducts root cause analysis with minimal guidance, applying it in moderately complex situations. Fully understands and applies Good Manufacturing Practices independently in various contexts. Executes Quality Assurance tasks independently, applying concepts effectively in routine and complex situations. Conducts audits with comprehensive understanding, applying principles in complex scenarios. Demonstrates advanced writing skills, capable of producing clear and concise documentation. Ensures safety assurance independently, applying safety concepts effectively in various situations. Applies quality control principles independently, understanding and implementing key concepts. Demonstrates practical experience in biotechnology, performing tasks independently and understanding biological processes. Independently applies process improvement techniques, understanding and implementing fundamental concepts. Communicates verbally with clarity and confidence, conveying messages effectively in various contexts. Important Considerations
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 controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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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 Investigation in a timely manner to support the 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 the 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 the department strategy What you bring to Takeda:
Typically requires a bachelor’s degree in science, engineering or other 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. Independently identifies flaws in Corrective And Preventive Action processes and implements corrective measures effectively. Conducts root cause analysis with minimal guidance, applying it in moderately complex situations. Fully understands and applies Good Manufacturing Practices independently in various contexts. Executes Quality Assurance tasks independently, applying concepts effectively in routine and complex situations. Conducts audits with comprehensive understanding, applying principles in complex scenarios. Demonstrates advanced writing skills, capable of producing clear and concise documentation. Ensures safety assurance independently, applying safety concepts effectively in various situations. Applies quality control principles independently, understanding and implementing key concepts. Demonstrates practical experience in biotechnology, performing tasks independently and understanding biological processes. Independently applies process improvement techniques, understanding and implementing fundamental concepts. Communicates verbally with clarity and confidence, conveying messages effectively in various contexts. Important Considerations
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 controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas. Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment. Work in a cold, wet environment. Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary. Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection. EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
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