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Job Description

About the role

The Change Control Specialist serves as a Subject Matter Expert (SME) and Owner in the performance/management of Quality Systems Change Control. As the change control specialist, you will prepare change control documents and coordinating change control activities from initiation through completion/implementation as defined in the change control requirements. You will also be the primary individual performing status update of changes in Trackwise 8 CCMS and JDE; and closure of change control documents. This position shall also serve as Digital Document Management Coordinator and Subject Matter Expert (SME) in Takada document format guidelines. Provide advanced GMP and analytical support to the Manufacturing operations team. Direct interactions with contractors, vendors, suppliers and customers may also be necessary. You will report to the Associate Director of Manufacturing Support

How you will contribute

• Generate change control documents for manufacturing and maintenance PM's and corrective maintenance.
• Manage content and closure of Level 1 and Level 2 changes including the assignment of actions/tasks to manufacturing and other support responsibilities.
• Manage performance of change control as measured by the measurements.
• Interface with Trackwise 8 CCMS, Veeva, LIMS, and JDE for coordination of change control documents and status updates.
• Collaborate with cross functional teams during change control review boards, QIT's, planning meetings to achieve quality and compliance goals, representing manufacturing change control team.
• Create technical reports by compiling technical information as defined by the change control requirements
• Perform documentation/formatting changes (SOP's, batch records, PM's, BOM's, product specifications) or create new documents.
• Coordinate periodic review of manufacturing related documents.
• Participate in critical safety and continuous improvement related activities in the site.
• Lead teams, encourage teamwork, and make sound assigned decisions ((e.g. technical, compliance, and operations).
• Respond to customer and management questions and problems related to projects/policies, etc.
• Analyze business processes and responsibilities to identify opportunities for continuous improvement.
• Reduce the cost of non-value-added activities and developing strategies to achieve department goals.
• Create and develop management tools, mechanisms for monitoring projects and main matrices.
• Maintain data integrity and ensure compliance with company SOP's and specifications, FDA, GLP. CSR and cGMP regulations investigate deviations and write exception documents.
• Perform other support activities for production needs.

What you bring to Takeda

• Typically requires bachelor's degree in science, engineering, or another related technical field.
• 5 years of related experience; some leadership experience.
• Understanding of critical manufacturing and facility processes/equipment.
• Understand scientific strategies and be able to create new processes or new avenues of Investigation.
• Have a high reading comprehension skill. Can communicate and Interpret data..
• Experience in JDE, DeltaV, Trackwise 8, LIMS, Veeva or similar systems.
• Apply logic-based decision-making to technical, compliance, or operational problems as assigned.
• Motivate people, encourage teamwork, teach investigational techniques, and assist Manager in driving team objectives.
• Will understand and apply cGMP/GDP, follow CTP/SOPs, and meet EHS requirements.
• Demonstrate knowledge of Quality systems.

Important Considerations

• The physical exertion of this position is sedentary work.
• May need to work in controlled or clean room environments requiring special gowning. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in this work
• May manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling and on-site transporting of hazardous wastes.
• Although assignments will be made specific to working hours, flexibility is expected, with the understanding that process validation and production objectives may necessitate changes in work hours and responsibilities.

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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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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