Assembler
- Cincinnati, OH
- Permanent
- Full-time
- 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.
- 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.
- 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
- 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
- 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
- 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
- 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.
- High School Diploma or general education degree (GED) strongly preferred.
- Prior manufacturing and/or assembly experience preferred.
- Prior experience in an FDA regulated production environment preferred.
- Learn and retain good documentation practices.
- Computer literacy / skills required (e-mail and Windows).
- Must have basic math skills and be able to perform step by step arithmetic calculations.
- Must show initiative, have critical attention to detail, and be organized.
- Develop interpersonal, organizational, written, comprehension, and oral communications skills.
- Ability to maintain regular attendance and punctuality requirements.
- Must be able to work overtime and weekends to support production efforts as needed.
- Develop problem solving and troubleshooting skills.
- 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 controls systems screens and written documents throughout the course of the workday.
- Must be able to detect audible and or visual alarms.