Transdermal - Material Control Coordinator (MCC)

Summary:Responsible for management of the reconciliation process during mixing, coating, slitting, converting, and packaging transdermal manufacturing operations. Provides guidance to technicians and operators on management of controlled substance raw material, semi-finished, and finished goods inventory. In addition to MCC responsibilities, must become certified Operator. Demonstrates commitment to the success of the department goals, supports the efforts of individuals, and teamwork in all aspects of job responsibilities. Contributes to team problem solving and production efforts. Must be able to perform the essential functions of the job, as listed in the Essential Function Analysis Form, with or without a reasonable accommodation. The essential functions and physical demands of this job can be found on the Essential Function Analysis Form for this position.Responsibilities:Accurately account and complete accounting forms, CSLS and spreadsheet Reconcile drug issued and usage accurately Provide direct supervision of drug in process areas Provide transportation of drug from vault to process areas and back to vault Provide continuous surveillance of the process areas Process and issue Controlled Substance sample requests Receive raw material (API) from supplier Dispose of waste in appropriate waste stream Store waste in appropriate storage location Account and record all waste produced during each process in appropriate forms Process waste for shipment Delivers samples to QC Lab Process shipment of samples, finished products and raw materials Performs various mechanical tasks in the operation of converting and packaging transdermal products. Operates designated automatic or semi-automatic equipment to convert and pack transdermal products. Picks, stages and maintains supply of packing materials for packaging transdermal products. Routinely inspects transdermal products for quality characteristics such as proper registration (or placement) of cutting, printing and sealing operations on the product. Performs inspection duties and manual pack-out required for the final packaging of product. Performs specific sampling, in-process testing and production reporting at assigned work station. Uses Labor reporting system by clocking into SO/WO accurately per production reporting SOP. Uses Paper or Computer based documentation system to input and record data results accurately Becomes certified and recertified in the Operator job classification within required timeframe. Operates manual power pallet jacks. Performs all department operations consistently at standard cost and quality levels and has sufficient knowledge of job duties to act as SME for training purposes. Recognizes quality improvement procedures that apply to area. Gives and accepts constructive feedback. Knows and uses good safety practices and takes ownership for running of a safe operation. Performs general housekeeping and cleaning of the assigned work area and assists in maintaining & ensuring converting & packaging area is clean and orderly at all times. Reports any property damage to supervisor immediately. Takes the initiative to help out when required or needed within total production operation. Hazardous Waste Duties including handling or generating hazardous waste and preparing hazardous waste for shipment and/or loading hazardous waste onto transport units. Performs other duties as requested and/or assigned. Adheres to all GMP and GDP guidelines and ensures data integrity at all times. Qualifications:Strong Mathematical skills Strong analytical/critical thinking skills Problem solving skills Communication skills Excellent attention to details Excel knowledge and high level skills Knowledge of GMP Ability to work in a highly regulated work environment Ability to work independently and in team environment Ability to work in a fast pace work environment (Flexible and Dependable) Accounting skills/experience Knowledge of Data Integrity principles Ability to use an inventory database Must have good manual dexterity to perform semi-repetitive tasks. Must be able to follow written and verbal instructions. Must be able to read, write legibly, understand and communicate in English, and have a general knowledge of math including metric conversions and percentages. Must be able to use basic computer systems for data entry. Must be able to occasionally lift up to 25 lbs. Preferred Skills & ExperienceAccounting skills/experience Knowledge of Data Integrity principles Experience working in an FDA regulated facility