Job Description

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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 uninterrupted production. You are responsible for sample management (sterility, stability) and preparing shipments of those samples. Additional responsibilities include and are not limited to Evaluation, Deviation/CAPA initiation and investigation, raw material investigations, QOTSF, online batch documentation review, and serving as an SME for processes. You will report to the Quality Operations Supervisor.

How you will contribute:

• Responsible for sample management (Sterility, stability) to appropriate facilities and responsible for appropriate storage and disposal of retention samples.
• Complete investigations in the event of a failure about processes or Raw Material that is deemed to be out of specification.
• Assess potential issues on the floor. Initiate deviation and complete investigation.
• Revise documents to procedures, forms, and specifications.
• Manage the appropriate storage and disposal of retention and reserve samples.
• Identify and assess quality risk in production operations daily. TIQ/QOTSF review of checklists and trending of observations for monthly quality council. TIQ/QOTSF program management and JDE work order initiation.
• Perform Returned Goods, Product Holds, and Tagging and Untagging of non-conforming material promptly.
• Responsible for the movement of materials/products physically and electronically for quarantine/reject areas and trained on PIT/forklift to move materials.
• Review and release pre-printed materials to manufacturing following cGMP procedures.
• Collect and submit rinse and bioburden samples to the laboratory.
• Oversee Manufacturing support activities including batch record documentation approval of OSI PI Reports, scanner card management, label copy control and issuance, raw material release, in-process work order release, and retention sample management.
• Ensure pre-printed material label cage is maintained in a GMP state while following all EHS and 5S guidelines.
• Operate and maintain quality operations equipment. Ensure that equipment maintenance is documented promptly.
• Support execution of conformance protocols with appropriate training
• Be a Subject Matter Expert (SME) and provide training to other members.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, and cGMP regulations.
• Monitor product quality through the performance of required visual and functional testing.
• Contribute to a team setting within the quality operations and potentially with other work teams to increase efficiency, create cost savings, improve quality, and provide new product support.
• Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Work with JDE, EBM, TW workflows, Systech and other LMS/DMS.

What you bring to Takeda:

• High School Diploma or GED with 4+ years of related work experience or Associates degree or higher and 2+ years of related work experience.
• Experience in pharmaceutical manufacturing of sterile drug and 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:

• 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.
• May work in confined spaces/areas.
• Some Clean Room and cool/hot storage conditions.
• May work with 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.
• Will work 2-2-3 shift, including weekends and holidays, to support a 24/7 manufacturing operation.
• Can work non-traditional work hours, including weekends and holidays.

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.

#GMSGQ

#ZR1

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Hourly Wage Range:

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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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