Responsible for assisting / performing facility, process, vendor and local validation activities to assure compliance with applicable federal, state, and local regulations as well as corporate policies, Good Manufacturing Practice (GMP), applicable ISO requirements and Standard Operating Procedures (SOP). Understand the voice of the customer and participate in identifying recommendations to the Quality Management. Assist in executing continuous improvement initiatives as supported by QMS metrics and/or site management. Approximately 5% of this role’s responsibilities are customer-facing (e.g. customer audit participation and correspondences via email and telephone).