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Change Control Specialist

2 months ago

Round Lake, United States Takeda Full time

Job Description

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 responsibility. 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:

Produce 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 (KPI). Communicate with Trackwise 8 CCMS, Veeva, LIMS, and JDE for coordination of change control documents and status updates. Collaborate with 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, problem-solve and make sound assigned decisions (e.g. technical, compliance, and operations). Respond to customer and management questions and problems related to programs/policies. Understand business processes and responsibilities to identify opportunities for continuous improvement. Reduce the cost of non-value-added activities, implementing strategies to achieve department goals. Create and develop management tools, mechanisms for monitoring projects and important 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. Experience with critical manufacturing and facility processes/equipment. Understand scientific strategies and be able to create new processes or new avenues of Investigation. Experience in JDE, DeltaV, Trackwise 8, LIMS, Veeva or similar systems. Can understand and apply cGMP/GDP, follow CTP/SOPs, and meet EHS requirements. What you bring to Takeda:

Typically requires bachelor's degree in science, engineering, or another related technical field. 5+ years of related experience.

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