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Job Description

About the role:

You will support commercial production of a the latest plasma processing facility for Takeda, focused on manufacturing for Fractionation, Albumin Purification, IG Purification, IG Filling, and biologic medication packaging. You will manage daily Quality Control Training Functions, develop, implement, and managing GxP and developmental training for Quality Control, collaborate with Quality Control Managers/Supervisors to ensure completion and documentation of regulatory and developmental training in Learning Management Systems. You will help create strategies to improve metric performance and guide strategic enhancements in areas such as New Employee training, New Employee Onboarding Systems, and Continued Education opportunities. You will report to the Quality Site Head.

How you will contribute:

• Support development and management of training plans for diverse Quality Control teams by conducting comprehensive gap analyses.
• Facilitate On-the-Job Training and provide essential support for e-learning requirements to ensure holistic skills development.
• Deliver specialized training on process knowledge to empower employees with the necessary expertise.
• Facilitate processes to ensure success of new hire training, including timely completion of assigned training modules.
• Track training assignments and adapt them through collaboration with testing teams.
• Facilitate communication to testing teams on training status to include reports on training completion, providing regular updates to leadership on training progress.
• Lead the development and revision of Standard Operating Procedures (SOPs), Job Aids, On-the-Job Training (OJT) materials, and Knowledge and Skill Assessments.
• Coach training testing team supervisors and leads to reach higher levels of effectiveness.
• Oversee the effectiveness of training programs.
• Implement special projects related to training and continuous improvement.
• Be a contact to troubleshoot and collaborate with site training team to resolve LMS system issues, representing Quality Control in LMS-related meetings and requirements.
• Manage the deployment of Environmental Health and Safety (EHS) incident response training in collaboration with operational teams.
• Participate in EHS investigations and own CAPAs to ensure the safety of our resources.
• Manage New Employee training and qualification associated processes, focusing on optimizing "Lead Time to Effectiveness" and "Readiness for the Floor."
• Deploy comprehensive training programs for new hires, including Process Knowledge, Takeda Learning Management Systems, and Good Laboratory Practices.
• Manage and deploy Onboarding, encompassing training and access verification for systems like labware, MODA and Trackwise.
• Lead the management and deployment of continued education opportunities, Takeda training systems, Qualified Trainer Program, external or additional trainings and shutdown training.
• Assess employees' knowledge and prepare evaluations.
• Conduct research to identify training methods and materials that contribute to analysts.
• Contribute to change control processes related to training.

What you bring to Takeda:

• Bachelor's Degree in Engineering, Chemistry, Biological Sciences, or equivalent, with 2-5 years' experience, or Master's Degree in Engineering, Chemistry, Biological Sciences, or equivalent with 0-3 years' experience. Laboratory coursework, or experience working in a laboratory.
• Contribute to cross-functional teams, applying a diverse skill set to enhance project outcomes.
• Have a customer service and leadership attitude, taking ownership of challenges and looking for solutions.
• Posses in-depth knowledge and functionality expertise in Learning Management Systems, allowing training program management and optimization.

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:

• Must be able to lift, push, pull and carry up to 50 lbs.
• 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.
• Facilitate on-shift delivery of training (non-routine).
• May work weekends and off shift.

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

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.

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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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