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Job Description

Job Title: Compliance Investigator

Location: Thousand Oaks, CA

About the role:

You will conduct root cause investigations, closes deviations, supports assignment of proper corrective actions, and facilitates implementation for Manufacturing under the direction of Compliance Management.

This is a hybrid role that reports to the Manufacturing Support Manager.

How you will contribute:

• Perform calculation, data collection to support site, global continuous improvement initiatives, and management reviews. Ensure that the daily operations of assigned functional area are met through scheduling, troubleshooting, and coaching. Use Global LIMS or other computerized systems for trending test results
• Participate in the development and technical writing of documentation for the validation of equipment and required to support testing of the Thousand Oaks Manufacturing Facility. Help generate test plans, protocols, and reporting documentation for the validation of equipment supporting testing and perform review of test data with application of GDP.
• Lead and guide completion of Lean or Six Sigma improvement projects and responsible milestones, as assigned. Support continuous improvement projects such as Yellow Belt, Green Belt, 5S, Kaizen, Just-do-it's, VIPs using Lean/DMAIC concepts and philosophy.
• May conduct investigations and audits into Alert/OOL excursions. Investigate deviations and write exception documents, using problem-solving tools as needed.
• Contribute to a team setting at the Thousand Oaks Manufacturing Facility and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support. Provide training and work direction for assigned functional areas.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations. May generate, execute, and/or summarize studies and review/revise of SOPs. Complete and direct completion of special project/protocol testing promptly.
• Assist Compliance Supervisor in updating department metrics, reporting shift activities and leading daily operations to ensure coordination and efficiency. Conduct mediations to ensure timely release of product for customers. Assist in meeting product release time goals.
• Write and manage deviations (CAPA investigations, UIs, ICARs, OOXs, containment and/or corrective actions) under the direction of Compliance Management. Lead the investigation closure of manufacturing compliance related documents. Use quality and statistical tools to identify and implement proper corrective and preventative actions to manufacturing non-compliance.
• Represent the departments during the product release process, compliance, and Continuous Improvement projects and audits. Participate in deviation related meetings and provide feedback, leadership, and support to manufacturing supervisors, trainers, and manufacturing technicians on the status of compliance of the department.
• Emphasize training programs designed to enable staff to execute all manufacturing processes with strict compliance to CGMPs and EHS regulations. May perform other duties as assigned.

What you bring to Takeda:

• Bachelor's degree preferred with 2-4 years of experience in a cGMP manufacturing or quality setting.

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:

• The overall physical exertion of this position is sedentary work.
• 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.
• Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Must be able to perform gowning operations, including donning over garment and head cover.
• May be required to balance and stand occasionally, when gowning and inside clean rooms.
• May be required to enter the production area and may therefore be exposed to hot, cold, and/or wet environments.
• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Although assignments will be made specific to working hours, flexibility is expected, with the understanding that process validation and production objectives may necessitate changes in work hours, duties, and responsibilities.

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

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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.

For Location:

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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