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Job Description

This position reports to Shift (3) Nights, which includes a shift differential according to the shift schedule. This shift schedule is Monday-Friday from 10 PM to 6:30 AM. Due to business need, on select occasion employees may be required to work overtime and/or support operations on an alternate shift. The company reserves the right to adjust your shift schedule, or location if necessary.

About the role:

You will perform all primary Quality Assurance activities for Teardown, Fractionation, and Purification observing cGMP, GDDP, FDA and Regulatory Standards, ISO requirements, and internal standard operating procedures. You will provide daily Quality on the Shop Floor oversight to manufacturing batch record and documentation review for accuracy and compliance to procedure, Quality on the Shop Floor walkthroughs to assure cGMP compliance and resolution of issues, participating in troubleshooting and problem solving of manufacturing issues and supporting daily Return to Operation assessment and Change Control (insignificant changes) process.

You will provide Quality Assurance support to Site Critical Systems, Facilities and Engineering processes.

You will assure compliance with cGMP, GDDP, and company procedures internal and external audits. Identify potential Quality and compliance risk in activities and processes according to procedural requirements, Takeda Quality Standards. Provide assessments to support good understanding of current regulatory requirements i.e., FDA, ISO, and Takeda Quality Systems, and serve as a plant resource for compliance to these requirements. Uphold Takeda's Quality Culture elements of keeping it simple, taking pride in doing it right, ensuring a speak up culture and overseeing and demonstrating commitment to Quality.

How you will contribute:

• Partner up with Manufacturing for Quality on the Shop Floor collaboration to ensure sound Quality decisions are made with compliance to standards and procedures.

• Perform scheduled and unscheduled walkthroughs of Manufacturing, facilities, and supporting areas for verification of acceptable cGMP Facilities and equipment conditions.

• Obtain resolution on issues identified as non-conformance. Interpret and evaluate issues for acceptability to standards, procedures and regulatory requirements. Help document issues with immediate corrections and corrective actions.

• Work with manufacturing teams in proactive functions that impact production, solve problems, improve quality, increase efficiency, create cost savings, and provide new product support.

What you bring to Takeda:

• High school diploma or GED. 6+ years of experience or AA or higher with 4+ years related work experience

Qualifications

• Knowledge of Regulations, Application of Good Data and Documentation Practices (GDDP) and application of current Good Manufacturing Practices (cGMP).

• General knowledge of biopharmaceutical / biotech manufacturing industry and systems.

• Good investigational experience. See the actual process on the floor (GEMBA) where issue occurred and recommend immediate corrections and corrective actions for determined root cause.

• Have good critical thinking and problem-solving skills (DMAIC and Lean).

• Perform and analyze trending using DeltaV system and EBM.

• Support department / plant goals.

• Approve investigations as assigned

• Yellow Belt/ Green Belt training or certification.

Physical Demands

• Must be able to lift, pull, and carry up to 25 lbs.

• In general, you will have a combination of sedentary work and walking around observing conditions in the cGMP facility.

Working Environment

• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

• Will work in a cold, wet environment.

• May work in a confined area.

• Some clean room and cool/hot storage conditions.

• Must be able to work multiple shifts, including nights, as assigned.

• Will work periodic overtime.

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. 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 Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-MA1

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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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