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Job Description

About the Role:

The Quality Operations V role is responsible for ensuring the quality of processes and product outputs, aligning with regulatory standards and Takeda's quality practices. You will focus on defining activities, processes, and standards to meet quality requirements, auditing processes, and ensuring product integrity. Review batch records and disposition of finished good batches. Also, you will be responsible for batch folder creation and initiation.

How you will Contribute:

• Follow Standard Operating Procedures to build required work. Prepare metrics related to responsibilities/expertise and escalate issues and appropriate.
• Collaborate to improve Quality System processes.
• Must maintain oversight of assigned batch folders. Troubleshoot atypical processing conditions and how to respond to them.
• Ensure the status of assigned batch folders is up to date and any issues have been escalated.
• Ensure all assigned training is completed.
• Support with investigations important to responsibilities/expertise.
• Execute initiation and reconciliation of controlled print documents.
• Deliver training materials relevant to area of expertise.
• Support Quality project teams.
• Support organization during regulatory audits.
• Knowledge of supplier/customer process streams and interdependencies.
• Assist with filing, and archival of documentation.

What you bring to Takeda:

• High School Diploma or GED with 4+ years of related work experience or associate degree or higher and 2+ years related work experience.
• Have a good understanding of cGMP regulations and Good Documentation Practices (GDP).
• Proficient in Microsoft Word, Excel, Outlook, and SharePoint.
• Knowledge of basic chemical and biological safety procedures.

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 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.
• 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-MA1

Takeda Compensation and Benefits Summary

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U.S. Hourly Wage 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