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Assembler (Finished Goods) 1st Shift Specialist

2 months ago

Cincinnati, Ohio, United States Meridian Bioscience Full time
Job Summary

The Assembler position at Meridian Bioscience requires the employee to learn and master the skills necessary to safely assemble, manufacture, and package regulated medical devices and kits in a performance-driven environment. Under the supervision of higher-level operators, supervisors, and managers, the Assembler will work to understand and meet all quality standards and adhere to all cGMP standards.

Key Responsibilities
  • Maintain a safe work environment by complying with all safety and environmental policies, including the use of personal protective equipment.
  • Expand knowledge of departmental operations to understand 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 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 required job tasks.
  • Demonstrate willingness to work with other departments and employees as required and accept instruction from higher-level positions.
Job-Specific ResponsibilitiesPara 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
  • Learn how to and become proficient in machine setup, machine operation, card inspection, and preventative maintenance.
  • Learn and become proficient in the routine tasks of pushing, catching, quality operations, and cleaning.
  • Contribute to the machine setup.
  • Learn how to clean and unload a lyophilizer.
  • 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.
  • Learn to inspect strips for acceptable/unacceptable material.
  • Learn how to load strips onto the assembly dial.
  • Learn how to complete manual assembly.
  • Learn to inspect devices for acceptable/unacceptable material.
Premier Production
  • 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
  • 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
  • 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
  • Learn how to initiate and complete KPR's.
  • Learn how to initiate and complete label requests.
  • Learn how to 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.
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 controls systems screens and written documents throughout the course of the workday.
  • Must be able to detect audible and/or visual alarms.