Assembler

Meridian Bioscience, Inc. • Newtown, OH

1d • Onsite

About The Position

The Assembler position at Meridian Bioscience requires the employee to learn how to safely assemble, manufacture, and package regulated medical devices and kits. This role operates in a performance-driven environment under the supervision of higher-level operators, supervisors, or managers. The employee is expected to understand and meet all quality standards and adhere to all cGMP standards. Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products, dedicated to delivering solutions with speed, accuracy, and simplicity.

Requirements

• High School Diploma or general education degree (GED) required.
• 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.

Nice To Haves

• Prior manufacturing and/or assembly experience preferred.
• Prior experience in an FDA regulated production environment preferred.

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.
• Demonstrate/ be competent in multiple skills in 2 departments, listed within the Job Specific responsibilities, through cross-training over several departments as instructed by management.
• Learn how to identify abnormal and out of specification components (Para Pak).
• Learn how to work all stations of the bagger (Para Pak).
• Learn how to catch, inspect, and package reagents and complete final case packaging (Para Pak).
• Learn how to label inner and outer cases (Para Pak).
• Learn how to identify labels utilizing the correct documentation (Para Pak).
• Learn how to complete the label reconciliation portion per the respective documentation (Para Pak).
• Learn to read and understand the Parts List used for every order (Para Pak).
• Learn to read and understand all applicable SP and EP documents and be able to reference these documents when necessary (Para Pak).
• Learn how to run the Macro Con labeling machine (Para Pak).
• Learn how to and become proficient in machine setup, machine operation, card inspection, and preventative maintenance (ImmunoCard Assembly - Rixan Production).
• Learn and become proficient in the routine tasks of pushing, catching, quality operations, and cleaning (ImmunoCard Assembly - Spotting/Blocking).
• Contribute to the machine setup (ImmunoCard Assembly - Spotting/Blocking).
• Learn how to clean and unload a lyophilizer (ImmunoCard Assembly - Lyophilizers to Vacuum Dry).
• Learn how to set up the assets (ImmunoCard Assembly - Campbell Wrapper/Bosch Poucher).
• Learn how to inspect packages per the respective procedures (ImmunoCard Assembly - Campbell Wrapper/Bosch Poucher).
• Learn how to perform Leak Testing per the respective procedure (ImmunoCard Assembly - Campbell Wrapper/Bosch Poucher).
• Learn to inspect strips for acceptable/unacceptable material (ImmunoCard Assembly - IDS Robotic Cell).
• Learn how to load strips onto the assembly dial (ImmunoCard Assembly - IDS Robotic Cell).
• Learn to inspect strips for acceptable/unacceptable material (ImmunoCard Assembly - manual assembly).
• Learn to assemble strips into the appropriate device (ImmunoCard Assembly - manual assembly).
• Learn to inspect devices for acceptable/unacceptable material (ImmunoCard Assembly - manual assembly).
• Learn how to operate, maintain and clean micro well plate coating and packaging room and equipment (Premier Production - Plate Coating).
• Learn how to produce, package and label coated microwell plates (Premier Production - Plate Coating).
• Learn how to set up/assemble microwell plates for production runs (Premier Production - Plate Coating).
• Learn how to set up sealer for coated micro well plates (Premier Production - Plate Coating).
• Learn how to set up balances (Premier Production - Plate Coating).
• Learn how to calibrate and operate single and multichannel pipettes (Premier Production - Plate Coating).
• Learn how to set up manual and automated dispensers (Dispensing).
• Learn how to manually label and crimp (Dispensing).
• Learn how to tip, stopper, and cap vials (Dispensing).
• Learn how to setup, operate, and be proficient on Accraply Labelling System (Dispensing).
• Learn how to calibrate and operate balances (Dispensing).
• Learn how to setup and monitor clean room (Dispensing).
• Learn how to properly gown for dispensing clean room (Dispensing).
• Learn how to setup, dispense, punch, inspect, and cleanup (Fungal - FID Plate Production).
• Learn how to assemble FID plates into the final packaging (Fungal - FID Plate Production).
• Learn how to calibrate and operate single (Fungal - FID Plate Production).
• Learn how to initiate and complete KPR’s (Kit Assembly).
• Learn how to initiate and complete label requests (Kit Assembly).
• Learn how set up and calibrate bench top scale (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 (Kit Assembly).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED