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Job Description

About the role:

As a Quality Insurance Specialist II, you will provide Quality Assurance support for Manufacturing process, Critical utilities, provide 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. You will provide support to manufacturing using Electronic Batch Management (EBM) and guidance to other team members. You will be responsible for multiple projects, demonstrate effectiveness in task completion, 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 or 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 departments.
• Assessments and information gathering may be through in-depth employee interviews, flowcharting, and other informational gathering.
• Review electronic batch records, identify nonconformance's and participate in investigation and Corrective and Prevention Action(CAPA).
• Provide training to local employees and others on relevant area(s).
• Write, analyze, and revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, and Regulatory Requirements.
• Oversee and audit of multiple reports (Protocols, Qualifications, Regulatory Submissions).
• Participate in QA multi-site projects in the role of contributor, coordinator or lead.
• Other duties, tasks or projects as assigned.

What you bring to Takeda:

• 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 be a team player.
• Ability to encourage teamwork and guide decisions.
• Will maintain metrics and drive team and external partners to meet metrics requirements
• Analytical and problem solving skills.
• Must have the ability to encourage teamwork and lead decisions.
• Knowledge of Microsoft Word, Excel, and PowerPoint.
• Knowledge of Electronic Quality Systems (TrackWise), Process control systems (Delta V, BAS, PLC), Electronic Batch Record Management.
• Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

Important Considerations

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

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. Base Salary Range:

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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