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Job Description

This position reports to Shift E (Weekend Nights), which includes a shift allowance according to the shift schedule. This shift schedule is Friday - Sunday from 6 pm to 6:30 am and one 8-hour day during the week. This shift requires working on all company-designated holidays. Due to business needs, on select occasions, 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 provide Quality Assurance support for Manufacturing process / Important utilities and providing Quality oversight and manufacturing support. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices. Provide support to manufacturing using Electronic Batch Management (EBM) and guidance to other team members.

The incumbent will be responsible for, demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.

How you will contribute:

• Responsible ongoing, daily departmental Quality Assurance support for Manufacturing process / Critical utilities. Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude through collaboration with production supervisors, engineering, and other internal groups.

• Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.

• Review electronic batch records, identify nonconformance's and participate in investigation and Corrective and Prevention Action(CAPA) activities

• Provide coaching to local employees and others on relevant area(s).

• Write, review and revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, Regulatory Requirements.

• Oversee, review, and audit of various reports (Protocols, Qualifications, Regulatory Submissions.)

• Participate in QA multi-site projects in the role of contributor, coordinator or lead.

What you bring to Takeda:

Education and Experience Requirements

• Typically requires Bachelors in Science / Business. In lieu of degree, 3+ years experience in Quality with a medical device/Pharma company or other similarly regulated industry.

• Must have the ability to encourage teamwork and guide decisions.

• Must have computer experience

• Knowledge of TrackWise, Delta V and Electronic Batch Record Management.

• Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

• Will maintain metrics and guide team and external partners to meet metrics requirements

• Analytical and problem solving skills.

• Must have the ability to encourage teamwork and guide decisions.

• Must have knowledge of FDA Regulations, Application of Good Laboratory

• Practice and Apply Good Manufacturing Practices.

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional training and development opportunities

• Tuition reimbursement

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:

• 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.

• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.

• Work multiple shifts including off hours, weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Aerosil that may require respiratory protection.

• May be required to work weekends, evenings, off-hours, and extended periods of time.

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.

This posting excludes Colorado applicants.

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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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