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Job Description

About the Role:

The primary responsibility is to serve the operations support group by ensuring compliance with procedures and regulatory requirements on the floor. You are responsible for investigations and escalation on the floor promptly to continue un-interrupted production. You are responsible for sample management (sterility, stability, etc.) and preparing shipments of those samples. Additional responsibilities incudes and are not limited to Triage, Deviation/CAPA initiation and investigation, raw material investigations, QOTSF, online batch documentation review, and serve as a Subject Matter Expert for processes.

How you will Contribute:

• Sample Management: Manage sterility, stability, and retention samples, ensuring proper storage and disposal.

• Investigations: Conduct investigations for process or raw material failures deemed out-of-specification, and triage on-floor issues, initiating deviations as needed.

• Document & Risk Management: Revise procedures, forms, and specifications; identify and assess quality risks in production operations, reporting findings in quality councils.

• Non-Conforming Material: Handle goods tagging, untagging, returned goods, product holds, and material movements (physical/electronic), including PIT/forklift operations.

• Material Review: Release pre-printed manufacturing materials, maintain the label cage per cGMP, and follow EHS/5S guidelines.

• Manufacturing Support Activities: Oversee batch record documentation, OSI PI reports, scanner card management, label control, raw material, in-process work order, and sample management.

• Equipment Operations: Operate, maintain, and document maintenance for quality operations equipment efficiently.

• Training & SME Support: Serve as SME, train members, and support execution of conformance protocols with adequate training.

• Compliance Management: Maintain data integrity, adherence to SOPs, FDA, GLP, and cGMP regulations, and monitor products via required testing.

• Audit & Team Contributions: Actively support regulatory audits and contribute to team efficiency, quality improvements, and new product support initiatives.

What you bring to Takeda:

• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)

• Proficient in Microsoft Word, Excel, Outlook, and SharePoint. Familiarity with JDE, EBM, TW workflows, Systech and other LMS/DMS.

• High School Diploma or GED with 4+ years of related work experience or an Associates degree or higher and 2+ years related work experience.

• Experience in pharmaceutical manufacturing of sterile drug and/or biologic solutions

• Some knowledge of applicable CTP/SOPs, EHS requirements, FDA Regulations, application of cGMP/GDPs

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:

• Experience indoor working conditions

• Work around moving equipment and machinery

• Work in controlled environments requiring special safety gear or gowning; will follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, nail polish, or artificial fingernails may be worn in the manufacturing environment.

• Work in confined spaces/areas.

• Encounter some Clean Room and/or cool/hot storage conditions.

• Work with and must not be allergic to cephalosporin.

• Will work 2-2-3 shift, including weekends and holidays, to support a 24/7 manufacturing operation.

• Will work non-traditional work hours, including weekends and holidays.

• Will work overtime.

• Will speak, read, write, and follow detailed written and oral instructions in English

• In general, your work will be a combination of sedentary work and walking around observing conditions of the facility.

• You may lift, push, pull, and carry up to 50 lbs without material handling equipment, and push or pull up to 150 lbs with material handling equipment

• You may 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/or squatting motions to perform certain tasks

• Repetitive motions with hands, wrists, turning head, bending at knees and waist

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 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.

#GMSGQ #ZR1 #LI-MA1

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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Job Exempt