Job TitleAbility to independently and accurately prepare all assigned records, calculations, and documentation. Demonstrated ability to independently and properly handle and dispose of hazardous waste. Ability to read and follow schedules, procedures, and documents. Demonstrated knowledge of safety precautions and procedures. Will be required to assist in training other employees in an area of responsibility as assigned. Assist staff in developing new procedures and methods or improving old ones. Ability to practice aseptic technique independently. Ability to perform media fills with (process simulation testing) with passing results per applicable SOP. Ability to perform clean room gowning and pass clean room garment validation consecutively. Ability to independently prepare disinfectants and sanitizing solutions. Ability to independently clean and sanitize production equipment, rooms and areas. Demonstrated knowledge of an aseptic operation and the relationship of laminar flow systems and environmental monitoring. Ability to assist in performing environmental monitoring, such as but not limited to, independently placing settling plates and air sampling. Ability to use basic hand tools. Ability to independently set-up, operate, maintain and troubleshoot steam sterilizers, capping machines, stoppering machines, bottle washers, sterilizing tunnels, equipment washing machines, sterile filtration equipment, L bar sealers/Bundler, vision systems, inkjets, vacuum check equipment as needed. Ability to wear a respirator if required of the job, no pulmonary restrictions. Ability to independently use and understand computer assisted data entry. Ability to independently perform sterile filtration. Ability to aseptically gather and transfer samples for QC testing. Ability to independently perform filter integrity and prepare accurate documentation Demonstrated ability to lift fifty (50) pounds. Demonstrated knowledge of Federal, State, and International regulations, such as cGMP, USDA, DOT, EPA, OSHA as they pertain to the employees work. Demonstrated knowledge of corporate guidelines and Policies related to the employees work. Demonstrated knowledge of Standard Operating Procedures (SOPs) related to the employees work. Demonstrated knowledge of Material Safety Data Sheets (MSDSs), safety procedures, and hazardous materials procedures. Demonstrated knowledge of aseptic processing procedures related to the employees work. Demonstrated knowledge of team process and leadership principles. Demonstrated knowledge of appropriate processes and theory related to the employees work. Demonstrated knowledge of documentation related to the employees work. Demonstrated knowledge of equipment as defined in Duties Additional education and/or equivalent experience. Successful completion of National Career Readiness Work Keys assessment. Knowledge of Traffic Patterns. Knowledge of or evidence of working with BPE Methods. Understanding of Basic GMP/Documentation practices. Demonstrated ability and understanding of safe working habits. Ability to work in a team environment. High School diploma or GED
