Ashley Wilhite, M.S. Email & Phone Number

Lake Forest, Illinois, United States

Lead Project Manager for FDA Submission of New Product NexJect Diazepam 1mL/2mL syringeLead Project Manager that established 1st floor DEA Control Drug Storage RoomLead Project Manager for Maintenance of Department’s DEA Scheduled Control DrugsLead Project Manager for Lab Equipment Qualification/ Validation (Instron, MecMesin, MicroVu, Software upgrades)Co-Lead Project Manager for Device Design Review for New Product NexJect Diazepam 1mL/2mL syringeCo-Lead Project Manager for Governance for New Product Development for the NexJect 0.5mL, 1mL, and 2mL syringe involving commercial, regulatory, and quality.Co-Lead Project Manager for FDA submission of New Product Development NexJect Hydromorphone 0.5mL syringeCo-Lead Project Manager for Closing R&D Device Testing Department at Lake Forest Site ~ close out site activities, transfer equipment to new site and help transfer/ re-write test methodsAuthored and Maintained over 400 Standard Operating Procedure (SOP), Test Method Validation (TMV), Test Method Transfers (TMT) Procedures, and Job AidsSubject Matter Expert on Test Method Validation Board ~ standardization of SOP, TMV, and TMT ProceduresGlobal Subject Matter Expert for LabWare- create protocols, trained new users, and maintained department workflows.Composed Manufacturing/Laboratory Incident Reports (MIR, LIR) as responsible person and laboratory technician.Maintained Laboratory budget and purchasing of supplies for in-house testing/ normal work activities.Global Trainer for validated equipmentGlobal Subject Matter Expert for Instron, Torque, Force, Tensile, and Compression

Lake Forest, Illinois

Alternate Lab Supervisor, Calibration Coordinator, and Hazardous Material/ Waster CoordinatorMaintained DCP Laboratory budget and purchased supplies for in-house testing/ normal work activitiesSubject Matter Expert for Controlled Drug Agent, Lab Equipment Qualification/ ValidationSubject Matter Expert for Instron Tensile/ Compression Machine/ Testing/ Writing ProceduresResponsible for writing and maintaining Lab’s Standard Operating ProcedureCo-Author Test Method Validation/ Test Method Transfers ProceduresWrote Work Instructions for GXP/GSP test proceduresGlobal TrainerMechanical engineering testing on pre-filled syringes, IV-bags - Instron, Torque, Force, Tensile, and CompressionUtilizing LabWare- create protocols, track inventory, data entryUtilizing QTS - Trackwise - Initiator, Action Owner, Responsible person-Manufacturing/Laboratory Incident Reports Utilizing PDOCs - Initiator, ApproverSafety Committee MemberEmergency Controlled Force Member - responsible person for an emergencyEHS Responsible person for DCP GroupMechanical engineering testing - Instron, Torque, Force, Break-Loose ExpulsionUtilizing SAP DMS System – SAP Production P01Manufacturing/Laboratory Incident Reports (MIR, LIR) utilizing Trackwise (QTS)Controlled Drug Agent – responsible person of controlled drugs Schedule 1 – 5

Lake Forest, Illinois

Pfizer Essential Health R & D Pharma Sciences group; Differentiated Drug Delivery (DDD) Group Mechanical engineering testing on pre-filled syringes.Alternate Laboratory CoordinatorAlternate Calibration Coordinator Alternate Hazard Material Coordinator Change Coordinator in SAP DMS for DDD groupControlled Drug AgentSafety Committee MemberECF (Emergency Control Force) MemberResponsible Person/ Approver/ Initiator for QTSInitiator/ Owner for PDOCsInitiator/ Owner for GDMSInitiator/ Owner for LIMS LabWare

Round Lake, Illinois

Research on Flow Systems for LV 1.5, 5.0, and 10.0 intermates/infusors. Validation of Infusor / Intermate System utilizing HP ALM. Instron testing of female and male luers. Gland Height, Cracking Pressure, Back Flow, Water Back Pressure, Radial Bond Strength, Removal Torque, Axial Pull Bond Strength, and Side Load Structural Testing for Check Valves. Axial Pull Testing on accelerated aging female/ male luers. Validation of a Flow System upgrade utilizing HP Quality Center.

Lake Forest, Illinois

Utilized SAP- Production P01Supported new product launches and product retirements.Reviewed all documentation for sales enablements and disablements. Managed sales of distribution of finished goods utilizing SAP to ensure regulatory and quality compliance. Closed all open request for 2014 and 2015, over 200 completed by April 2016. Dropped average of open requests from 266.4 days to 62.1 days.

Round Lake, Illinois

Jan. 2015 - Oct. 2015: CAPA investigations in Global Medical Product Division. Material Characterization of Aging Study with Dual Chamber Fluid IV Bags. Oct. 2012 - Jan. 2015:Research to combine different versions of the same medical product into an universal product worldwide.Plastic issue- resin formulations changed, adapting new formulations to current productsExtrusion lab- compounding, extruding, Tubing, and making plastic film for testing. Peel Seal and Inter-Layer Adhesion Instron TestingMaterial Characterization, DSC, Tensile Testing, Heat Sealing,Peel Seal Testing, WVTR, OTR, Haze, Clarity, Impact.

Master'S Degree, Project Management, A. 4.0

Activities and Societies: National Society of Leadership and SuccessMaster of Science in Project Management Operations.

Bacheleor'S, Biology Emphasis On Microbiology

Activities and Societies: Post Office Food Drive 1994-2007, Alzheimer’s Walk 2004, Be Bop Dance Class 2004, Big Pink Volleyball.