Job Description

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  • Ensures compliance with Food and Drug Administration (FDA) regulations and all policies, guidelines, and standard operating procedures (SOPs) related to change control.

  • Processes change control request documentation related to cGMP manufacturing processes and SOPs for plasma centers and plasma operations, including but not limited to: product manufacturing / procedural changes, equipment changes, customer changes, supplier (contractor) changes, and facility changes.

  • Tracks and maintains change control request documentation throughout its lifecycle: creation/revision, review and approval, implementation, closure. Ensures tasks are completed in a timely manner.

  • Coordinates change control process to ensure timely delivery of change requests and information to customers, including plasma centers and plasma operations, as required.

  • Communicates with other departments, including Corporate, Field management, and Center-level custome...
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