• Responsible for designing, creating, reviewing, approving, storing and change control of single panel labels, booklet labels and booklet cover pages• Retrieve foreign language translations from Phrase Translation Management System for all clinical trial studies and submit for approvals from Country Medical Department.• Create, Review and approve ClinPro entities: Models, Container Types, Processes, Assignment Sets, Patient Position, Interval Position, Treatment Group Position and Generation Specifications• Define job specific parameters such as comet lot number, use by date, date of manufacture, label and ribbon stock details• Define treatment group sets or material treatment sets by defining treatment arms and import the random codes through a random code generation system (Ramos, RanALL)• Responsible for printing and inspecting all clinical trial supply labels ensuring they meet all regulatory requirements and make comparisons against all treatment groups, the Master Label and Label Definition Contract • Interact with Supply Chain Managers, Clinical, Packaging Operations, Country Medical Department and External Contractors• Write detailed batch records in accordance with cGMP's, SOP's, Protocols, Specification Orders and Label Definition Contracts to ensure packaging documentation is 'Right First Time'• Order and Track inventory of all single panel and booklet label stock using Comet Inventory.• Performs audits to the system to review the list of users to ensure only current GDS or Information Systems employees have an active ClinPro Account. Provide training and give access to ClinPro• Operate labeling equipment such as Webtechniques Model WT-25 LC1 Roll label Rewind Machines, Zebra 170 xi III Plus and laminator• Works on more complex study designs (Cross over studies, Commercial Packs)• Reviews executed Batch Records prior to submission to Quality Assurance to insure adherence to cGMPs and proper documentation of information

• Operate packaging equipment, such as the Semi-Automatic Tamp-down Labeling Machine, CCL Labeler, Enercon Induction Heat Sealer, Kalish Semi-automatic Bottle Cleaner, Electronic Torque Tester, Swift pack Bottle Filler, Swanmatic & Kalish Cappers, and the Accraply 5005 Dual Head Labeler.• Responsible for primary filling and secondary packaging of Clinical Trial Materials and the completion of all clinical supplies documentation.• Set-up, sign-in and dispense all fill and packaging components required based on the packaging batch record.• Allocate and dispense components using Comet Inventory System.• Qualified Trainer: Ensures personnel are trained in procedures/policies for manufacturing and packaging products, according to cGMPs, EOPs, and SOPs.

Operate all aseptic vial filling/lyophilizing lines andpackaging equipment during production runs.* Perform assignments in the aseptic filling and packagingareas in accordance with working directions, standardoperating procedures, cGMP’s and GlaxoSmithKline safety& quality directives.* Qualified on proper aseptic techniques and sterile gowningprocedures.* Responsible for coordinating and organizing line set ups,sign in components, recognize and report all deviations tosupervisor.* Monitor all data collecting systems such as the Met-OneSystem and Kaye Recorders.* Provides training and skills development to ensureemployees are competent and qualified to perform dutieswhile complying with standard procedures and regulatoryrequirements.* Complete accountabilities and component returns.* Review all paperwork for accuracy before finalreconciliation of jobs.* Perform powder weight checks and analyze gas/carbondioxide during powder fills.* Responsible for overseeing all personnel while runningpowder filling and packaging line.