Assembler

Meridian Bioscience, Inc.•Newtown, OH

2d•Onsite

About The Position

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.

Requirements

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.
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.

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.
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.
When in Para Pak: Learn how to work all stations of the bagger.
When in Para Pak: Learn how to catch, inspect, and package reagents and complete final case packaging.
When in Para Pak: Learn how to label inner and outer cases.
When in Para Pak: Learn how to identify labels utilizing the correct documentation.
When in Para Pak: Learn how to complete the label reconciliation portion per the respective documentation.
When in Para Pak: Learn to read and understand the Parts List used for every order.
When in Para Pak: Learn to read and understand all applicable SP and EP documents and be able to reference these documents when necessary.
When in Para Pak: 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.
When in Spotting/Blocking: 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.
When operating the Campbell Wrapper/Bosch Poucher: Learn how to inspect packages per the respective procedures.
When operating the Campbell Wrapper/Bosch Poucher: Learn how to perform Leak Testing per the respective procedure.
When operating the IDS Robotic Cell: Learn to inspect strips for acceptable/unacceptable material.
When operating the IDS Robotic Cell: Learn how to load strips onto the assembly dial.
When completing manual assembly: Learn to inspect strips for acceptable/unacceptable material.
When completing manual assembly: Learn to assemble strips into the appropriate device.
When completing manual assembly: 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.
When in Plate Coating: Learn how to produce, package and label coated microwell plates.
When in Plate Coating: Learn how to set up/assemble microwell plates for production runs.
When in Plate Coating: Learn how to set up sealer for coated micro well plates.
When in Plate Coating: Learn how to set up balances.
When in Plate Coating: Learn how to calibrate and operate single and multichannel pipettes.
When in Dispensing: Learn how to set up manual and automated dispensers.
When in Dispensing: Learn how to manually label and crimp.
When in Dispensing: Learn how to tip, stopper, and cap vials.
When in Dispensing: Learn how to setup, operate, and be proficient on Accraply Labelling System.
When in Dispensing: Learn how to calibrate and operate balances.
When in Dispensing: Learn how to setup and monitor clean room.
When in Dispensing: Learn how to properly gown for dispensing clean room.
When in FID Plate Production: Learn how to setup, dispense, punch, inspect, and cleanup.
When in FID Plate Production: Learn how to assemble FID plates into the final packaging.
When in FID Plate Production: Learn how to calibrate and operate single.
When in Kit Assembly: Learn how to initiate and complete KPR’s.
When in Kit Assembly: Learn how to initiate and complete label requests.
When in Kit Assembly: Learn how set up and calibrate bench top scale.
When in Kit Assembly: 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.
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.