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Job Description

About the role:

The Lead Investigator will initiate and execute deviations in support of Manufacturing. Responsibilities include defining problem statements, documenting current state, conducting root cause analysis, implementing corrective actions, and verifying that the corrective actions were effective in resolving the issue. The incumbent provides technical support to the manufacturing functions which includes filling, inspection, and packaging operations. In addition, the incumbent works closely with the corresponding manufacturing, quality assurance, or critical system personnel to investigate suspect results. Responsibilities include leading investigation teams and driving root cause identification and preparing presentation for management.

How you will contribute:

• Conduct and document Investigation in a timely manner to support the on-time closure of non-conformances to meet product fulfillment dates.
• 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.
• Actively contributes to a team setting, increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support, as needed. Lead or support Deviation Free Initiatives
• Work closely with other QA departments and manufacturing operations to conduct investigations, determine appropriate corrective actions, and drive closure of deviations in accordance with cGMP and quality systems.
• Maintain access to key quality system databases and ensure accuracy of those databases as they pertain to CAPA and other quality databases.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Investigate deviations and write exception documents, when assigned.
• Ensure training requirements are met and that training records are current. Train and mentor other team members and support training for newer team members.
• Prepare root cause and/or trend analysis to management during routine operation mechanisms (e.g., Management Review and CAPA Review Board).

What you bring to Takeda:

• Typically requires a bachelor’s degree in science, engineering or other related technical field and 2+ years of related work experience.  Some leadership experience preferred.
• Technical writing experience preferred.
• Ability to work independently.
• Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
• Effective organizational skills, detail oriented, and ability to plan and suggest resolutions to technical or resource problems.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).
• Effective interpersonal communication and influencing skills.  Must have effective verbal and written communication skills. 
• Understand scientific strategies and be able to create new processes or new avenues of investigation.
• Must be able to understand and apply cGMP/GOP, follow CTP/SOPs, and meet EHS requirements.
• Demonstrate good process and critical system understanding to create comprehensive investigation write up.
• Capable of navigating through Quality systems and has working knowledge of event management system.

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.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ  #ZR1  #LI-Onsite

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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U.S. Base Salary Range:

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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Job Exempt