Cincinnati
The Assembler position requires the employee to learn how to safely assemble, manufacture, and package regulated medical devices and kits in a performance driven environment under the supervision of higher-level operators/Supervisors/Managers. The employee will work to understand and meet all quality standards and adhere to all cGMP standards. Tasks/Duties/Responsibilities: • Maintain a safe work environment by complying with all safety and environmental policies including the use of PPE., • Expand upon limited knowledge of departmental operations to understand the equipment and processes., • Perform manual and automated assembly/packaging of commercial diagnostic products and kits., • Read, understand, and comply with current Good Manufacturing Practices and Standard Operating Procedures., • Learn to operate and maintain automated production equipment with direct supervision of a trained operator or higher., • Complete daily documentation required for production procedures and supplemental documentation as needed., • Audit own paperwork for corrections, missing, and/or incomplete information ensuring that it is neat, accurate, and legible., • Comply with all OSHA, FDA, ISO, Quality system, Company and departmental requirements., • Learn to perform calibrations and routine process monitoring as needed., • Conduct in process sampling and/or inspections and document per procedure., • Monitor inventory for the purpose of fulfilling daily production needs., • Identify and communicate any/all abnormal components and deviating events to the Group Leader/Supervisor/Manager., • Learn to use necessary computer programs for the required job tasks., • Demonstrate willingness to work with other departments and employees as required and accept instruction from higher level positions., • Operator or higher-level employee attention is required at this level., • Other duties as required., • Must be able to demonstrate/be competent in multiple skills in 2 departments, listed within the Job Specific responsibilities above, through cross-training over several departments as instructed by management. Job-Specific Responsibilities (but not limited to): Para Pak • When in Para Pak, • Learn how to identify abnormal and out of specification components., • Learn how to work all stations of the bagger., • Learn how to catch, inspect, and package reagents and complete final case packaging., • Learn how to label inner and outer cases., • Learn how to identify labels utilizing the correct documentation., • Learn how to complete the label reconciliation portion per the respective documentation., • Learn to read and understand the Parts List used for every order., • Learn to read and understand all applicable SP and EP documents and be able to reference these documents when necessary., • Learn how to run the Macro Con labeling machine. ImmunoCard Assembly • When in Rixan Production, • Learn how to and become proficient in machine setup, machine operation, card inspection, and preventative maintenance., • When in Spotting/Blocking, • Learn and become proficient in the routine tasks of pushing, catching, quality operations, and cleaning., • Contribute to the machine setup., • When operating the Lyophilizers to Vacuum Dry, • Learn how to clean and unload a lyophilizer., • When operating the Campbell Wrapper/Bosch Poucher, • Learn how to set up the assets., • Learn how to inspect packages per the respective procedures, • Learn how to perform Leak Testing per the respective procedure, • When operating the IDS Robotic Cell, • Learn to inspect strips for acceptable/unacceptable material, • Learn how to load strips onto the assembly dial, • When completing manual assembly, • Learn to inspect strips for acceptable/unacceptable material, • Learn to assemble strips into the appropriate device, • Learn to inspect devices for acceptable/unacceptable material Premier Production • When in Plate Coating, • Learn how to operate, maintain and clean micro well plate coating and packaging room and equipment, • Learn how to produce, package and label coated microwell plates, • Learn how to set up/assemble microwell plates for production runs, • Learn how to set up sealer for coated micro well plates, • Learn how to set up balances, • Learn how to calibrate and operate single and multichannel pipettes Dispensing • When in Dispensing., • Learn how to set up manual and automated dispensers, • Learn how to manually label and crimp, • Learn how to tip, stopper, and cap vials, • Learn how to setup, operate, and be proficient on Accraply Labelling System, • Learn how to calibrate and operate balances, • Learn how to setup and monitor clean room, • Learn how to properly gown for dispensing clean room Fungal • When in FID Plate Production, • Learn how to setup, dispense, punch, inspect, and cleanup., • Learn how to assemble FID plates into the final packaging., • Learn how to calibrate and operate single Kit Assembly • When in Kit Assembly, • Learn how to initiate and complete KPR's., • Learn how to initiate and complete label requests., • Learn how set up and calibrate bench top scale., • Learn to assemble and perform functions including but limited to pre-assembly stuffing of components, labeling of kit boxes, and weighing kits per the respective production procedures. Other Duties/Physical Requirements: • Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility., • Must have the ability to inspect, analyze and concentrate throughout the course of the work shift., • Must be able to concentrate and problem solve routinely throughout the course of the work shift., • Must have fine manual dexterity to ensure precise assembly of medical devices., • Must have the ability to lift up to 25-50 pounds of supplies or finished product throughout the work shift., • Ability to stand and/or sit for long periods, stoop, reach, bend, push and pull carts and hand jacks throughout the course of the work shift., • Ability to wear all required personal protective equipment (lab coat, safety glasses, hair coverings, latex or nitrile gloves), • Must be able to identify and differentiate color and color changes on diagnostic devices and device components., • Must be able to read, navigate, and operate control systems screens and written documents throughout the course of the workday., • Must be able to detect audible and or visual alarms. Minimum Education or Equivalent Experience Required/Preferred: • High School Diploma or general education degree (GED) required., • Prior manufacturing and/or assembly experience preferred., • Prior experience in an FDA regulated production environment preferred. Comp