Change Control Specialist

3 days ago


Round Lake Beach, Illinois, United States BioSpace, Inc. Full time
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.

Key Responsibilities
  • Prepare change control documents and coordinating change control activities from initiation through completion/implementation as defined in the change control requirements.
  • 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.
  • 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.


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