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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:

• Performs Acceptable Quality Limit (AQL) sampling of finished product. Identify and assess quality risk in production operations daily.
• Accomplish Total Integrated Quality (TIQ)/ Quality on the Shop Floor (QOTSF) and review of checklists. Programs are part of manufacturing support and compliance enforcement.
• Initiate JDE (inventory management system and preventive maintenance system) work orders if required to address issues.
• Perform sample management (Sterility, stability) to appropriate facilities and responsible for appropriate storage and disposal of retention samples. Samples Raw Materials in an ISO Classified environment, including preparation and shipment of samples to the required laboratories.
• Initiate investigations in the event of a failure of processes or Raw Material that is deemed to be out of specification.
• Perform assessment with manufacturing, engineering, and maintenance to resolve potential issues on the floor and escalate.
• Facilitate kitting operations for packaging – issue and return of preprinted materials physically and electronically.
• Handle movement of materials/products physically and electronically for quarantine and reject areas.
• Review Lead Manufacturing support activities including batch record documentation review. Perform approval of batch documentation and consult with manufacturing to address any required corrections.
• Subject Matter Expert (SME) and provides training to other employees.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations.
• Monitor product quality through the performance of required visual testing follow ups.
• Contribute to a team setting within quality operations and potentially with other work teams to increase efficiency, produce cost savings, improve quality, and provide new product support.
• Support regulatory audits.
• Work with JDE, EBM, TW workflows, Systech and other Learning Management and Document Management systems.

What you bring to Takeda:

• High School Diploma or GED with 2 years of related work experience or Associates degree or higher and 1 years related work 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. You may:

• In general, your work will be a combination of sedentary work and walking around observing conditions of the facility.
• Must be able to carry up to 10lbs, lift up to 10lbs, push/pull up to 20lbs (with assistance of material handling equipment).
• Must be able to stand and/or walk for an extended period over an 8–12-hour shift between rooms and across the site.
• May require bending, twisting, reaching overhead, and squatting motions to perform certain tasks.
• Repetitive motions with hands, wrists, turning head, bending at knees and waist.
• 20/20 near and distance vision (Applies to roles performing visual inspection only) with or without glasses and contacts.
• May not be colorblind (Applies to roles performing visual inspection only).
• Indoor working conditions.
• Will work around moving equipment and machinery.
• Some Clean Room and cool/hot storage conditions.
• May experience and must not be allergic to cephalosporin.
• 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 artificial fingernails while in the manufacturing environment.
• May work in a cold, hot or wet environment.
• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Can work non-traditional work hours, including weekends and holidays.
• Will work a 12-hour shift (6:00am – 6:30pm), in a 2-2-3 rotation, including weekends and holidays, to support a 24/7.
• Can work overtime.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.

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Takeda Compensation and Benefits Summary

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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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