Clinical Supplies Packaging Operator

In accordance with specific instructions, performs a variety of functions involved in the preparation of packaged clinical supplies including operation of semiautomatic and automatic machines necessary for filling, labeling, capping and sealing a variety of vials, bottles, ampules, tubes, unit dose blister cards or other containers prepared for use in clinical studies, clinical stability or product registration use. Assembles, operates, disassembles and cleans equipment and performs routine calibration and adjustment of equipment operating parameters. Performs in process sampling during operations and records data obtained. Weighs and/or handcounts dosage forms and records data obtained within the appropriate documents. Inspect labels (manually and with use of electromechanical equipment) against label proofs and other supporting documentation for confirmation of but not limited to the following characteristics: Count, Variable text, Character verification and Cosmetic defects. Label inspection must be accurate with no room for deviations. Completes all documentation supporting the preparation of clinical supplies and label inspection through interface with software based processing instructions and data collection systems and use of equipment PLC's. Performs product inspection of supplies using SAP interface or other electromechanical equipment for verifying contents. Through interface with SAP performs calculations of label and product accountabilities. Alerts supervision of any irregularities in procedures or equipment operations Makes up carriers and shippers and prepares finished supplies for shipment. Assist in the (re)qualification and (re)validation of processing equipment. Where a sterile environment is necessary, cleans and wipes ceilings, floors and walls in the prescribed manner and exposes sterile plates to monitor sterility. Performs other duties of equal or lesser in nature as required such as but not limited to; movement of material between work locations, organizing CSO warehouse and general housekeeping. Follows Current Good Manufacturing Practices, departmental SOP's, good housekeeping principles and all safety rules. Interfaces with computer based applications for self paced on line training of both company and departmental policies and procedures. Perform as required Visual Inspection of Parenteral Products (i.e. Liquid filled and Lyophilized vials and syringes). This requires individuals to pass qualification and Biennial requalification.