Operator I Location: Cincinnati, OH Duration: 5 months with possible contract to hire Description: Accepting candidates that have high school diploma or GED. Workers must be willing to stand for duration of assignment and bend. Workers are not operating a forklift. Workers may be working in the packaging or manufacturing areas. Most of the work will be in packing. Packing consist of taking the pills and getting them into the packages. They may be filling bottles, working with the machine’s that put the pills into the container. In manufacturing, workers will be mixing, going up small ladders up to 6 feet and lifting up to 50 pounds. Position Summary: This position is responsible for performing operations related to the manufacturing and/or packaging of pharmaceutical products through equipment set-up, operation, clean-up and maintenance in compliance with all regulatory cGMP requirements and company policies and procedures. Essential Duties & Responsibilities All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. Responsible for learning the manufacturing and/or packaging process as assigned by following approved batch records (BR), work instructions (WI), standard operating procedures (SOP), etc. Responsible for set up, changeover, programming and operation of various equipment manufacturing and/or packaging equipment. Responsible for cleaning of facilities, equipment and utensils as required following SOP’s and WI’s. Responsible for completing documentation as required in the manufacturing and/or packaging of product. Responsible for completing all training requirements and maintaining 100% compliance with all assignments. Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions. Responsible for performing additional related duties as assigned. Position Requirements Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. Preferably previous pharmaceutical manufacturing or packaging experience. Education/Certification/Experience: Requires High School Diploma or equivalent. Prefer previous experience in a manufacturing environment within pharmaceutical, nutraceutical or food processing industries. Skills/Knowledge/Abilities: Ability to receive instruction and follow directions. Ability to interact positively with co-workers and management. Ability to communicate effectively with written and oral communication skills. Ability to follow company policies and procedures. Ability to follow cGMP and other regulatory requirements. Ability to maintain 100% compliance in all SOP, cGMP, EHS and other training curriculum as assigned. Ability to operate and troubleshoot manufacturing/packaging equipment. Problem Solving: Works on assignments that are routine to semi-routine in nature where the ability to recognize deviation from accepted practice is required. Exercises judgment within specifically defined practices and policies and selects methods and techniques for obtaining solutions. Normally receives general instruction on routine work and detailed instruction on new assignments. May be asked to recommend methods and procedures for problem resolution. Physical requirements: Constant: Standing for extended periods of time at work station or equipment. Walking to move short distances quickly and frequently. Frequent: Stooping, Kneeling and/or Crouching – bending body, spine and/or legs. Twisting/Reaching – turning at waist and extending hands and/or arms in any direction. Occasional: Sitting for extended periods of time at work station or mobile equipment. Climbing – use of feet, legs, hands and/or arms to ascend or descend. Pushing and/or Pulling – using upper extremities to exert force. Repetitive Motions - frequent motions of the wrists, hands and/or fingers. Lifting – raising from lower to upper and/or moving objects horizontally – from 25 lbs, up to 50 lbs. and more than 50 lbs (with assistance) Visual Acuity: Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes