By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

The primary responsibility is to ensure compliance with procedures and regulatory requirements in the manufacturing facility. You are responsible for quality support and oversight of manufacturing operations, which includes presence on the floor and for performing Acceptable Quality Limit (AQL) sampling of finished product. Additional responsibilities include assessment for potential issues on the floor, raw material investigations, Quality on the Shop Floor (QOTSF), online batch documentation review, sample management, kitting of batches, and raw materials release.

How you will contribute:

• Help develop lab test methods on raw materials, initial, in-process and final products, and samples collected from environmental monitoring programs at Shire manufacturing facilities.
• Help with the installation and validation of laboratory instrumentation and computer systems to collect and record data.
• Perform advanced assays requiring precise analytical skills and understanding of microbiology and chemistry principles.
• Complete all testing, including special project / protocol testing.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
• Investigate deviations and write exception documents.
• Participate in functions involving teams, which impact production, increase efficiency, create cost savings and improve quality.
• Perform laboratory and manufacturing audits. Audit and update, plant SOPs.
• Perform equipment maintenance and calibrations.
• Willingness to train others and communication with supervisors and peers
• Advanced laboratory skills and basic knowledge of statistical method.
• Knowledge of laboratory equipment including autoclaves, incubators, and analytical equipment.
• Proficiency in different mathematical operations and calculations and be able to work with both the metric and US standards of measurement.
• Knowledge of Microsoft Word, Excel, and PowerPoint.
• Knowledge of basic chemical and biological safety procedures.

What you bring to Takeda:

• High school diploma or equivalent. Some related work experience 0-3 years' experience.

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:

• May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• 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 B