Sarah Fudge

Performed compounding of pharmaceutical products

Received API and components based on the bill of materials. Performed potency calculations using QC sampling results. Set up and operated CIP/SIP skid to prepare tanks and equipment for compounding and filtration according to batch records. Verified performance of balances, scales, load cells, and equipment. Dispensed and charged API according to batch requirements. Mixed solutions and heated them using steam to required temperatures. Cooled solutions using a chiller to meet batch standards. Conducted pH and osmolality sampling and testing. Documented processes and transferred in-process and bioburden samples. Calculated and maintained filtration flow rates. Reconciled product and batch yields, reviewing for accuracy. Cataloged critical process parameters. Collaborated with QA to address process deviations. Coordinated with maintenance, metrology, R&D, and validation for equipment repair and performance verification.

Compounding Process Improvement

Identified process inefficiency in Media Fill procedure; drafted Change Control appeal for batch record and Media Fill protocol. Articulated proposed rectifications at Operations Conference, leading to implementation that reduced mandatory day from 13 hours to 8 hours.

Identified equipment inefficiency; created prototype in Onshape (CAD) and assembled working model with PVC pipe. Submitted design for production using approved materials.

Reviewed full work history on additional page