BioSpace
Manufacturing Investigation, Principal Analyst
BioSpace, Round Lake Beach, Illinois, United States
Overview
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 investigations 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
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. 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. 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. Role and Environment
At Takeda, our patients rely on us to deliver quality products. In this role, you may work in a controlled manufacturing environment requiring gowning and protective clothing, and may include shifts, weekends, and exposure to chemicals. The environment may be cold and wet. More About Us
Takeda is a patient-focused company that emphasizes an inclusive, collaborative workplace and is certified as a Global Top Employer. We strive for excellence and are committed to delivering Better Health and a Brighter Future to people around the world.
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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 investigations 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
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. 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. 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. Role and Environment
At Takeda, our patients rely on us to deliver quality products. In this role, you may work in a controlled manufacturing environment requiring gowning and protective clothing, and may include shifts, weekends, and exposure to chemicals. The environment may be cold and wet. More About Us
Takeda is a patient-focused company that emphasizes an inclusive, collaborative workplace and is certified as a Global Top Employer. We strive for excellence and are committed to delivering Better Health and a Brighter Future to people around the world.
#J-18808-Ljbffr