Quality Assurance Associate - Sterility

Provide technical and SME input for various programs including Process, Aseptic, Cleaning Validation, and Contamination Control Strategy, while maintaining lifecycle documentation.

Collaborate with area owners and suppliers to finalize validation/qualification requirements for facilities, processes, equipment, and systems, ensuring adherence to all relevant policies and regulations.

Author and develop Elanco Functional Procedures (EFPs) for Contamination Control, sterile/aseptic processes, cleaning, and disinfection validation plans.

Assist in troubleshooting, performing gap/risk assessments, providing support for regulatory inspections, and conducting necessary training.

Provide oversight during the execution of (re)validation/qualification activities for manufacturing, aseptic processing, media fills, media holds, and sterilization cycles, and support corrective actions including...