Assembler

About the Role

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy, and simplicity. This 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, or Managers.

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 equipment and processes.
• Perform manual and automated assembly/packaging of commercial diagnostic products and kits.
• Read, understand, and comply with current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs).
• Learn to operate and maintain automated production equipment with direct supervision.
• Complete daily documentation required for production procedures and supplemental documentation as needed.
• Audit own paperwork for corrections, missing, 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 to fulfill daily production needs.
• Identify and communicate any 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.
• Become competent in multiple skills across at least two departments through cross-training as instructed by management.

Job-Specific Responsibilities

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 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 reference them when necessary.
• Learn how to run the Macro Con labeling machine.

ImmunoCard Assembly

• Rixan Production: Learn and become proficient in machine setup, operation, card inspection, and preventative maintenance.
• Spotting/Blocking: Learn and become proficient in routine tasks of pushing, catching, quality operations, and cleaning; contribute to machine setup.
• Lyophilizers to Vacuum Dry: Learn how to clean and unload a lyophilizer.
• Campbell Wrapper/Bosch Poucher: Learn how to set up assets, inspect packages per respective procedures, and perform leak testing.
• IDS Robotic Cell: Learn to inspect strips for acceptable/unacceptable material and load strips onto the assembly dial.
• Manual Assembly: Learn to inspect strips and devices for acceptable/unacceptable material and assemble strips into the appropriate device.

Premier Production

• Plate Coating: Learn how to operate, maintain, and clean micro well plate coating and packaging room and equipment; produce, package, and label coated microwell plates; set up/assemble microwell plates for production runs; set up sealer for coated micro well plates; set up balances; calibrate and operate single and multichannel pipettes.
• Dispensing: Learn how to set up manual and automated dispensers; manually label and crimp; tip, stopper, and cap vials; set up, operate, and become proficient on the Accraply Labelling System; calibrate and operate balances; set up and monitor the clean room; properly gown for the dispensing clean room.
• Fungal: Learn how to set up, dispense, punch, inspect, and clean up FID plate production; assemble FID plates into final packaging; calibrate and operate single-channel equipment.
• Kit Assembly: Learn how to initiate and complete KPRs and label requests; set up and calibrate bench-top scales; assemble and perform functions including pre-assembly stuffing of components, labeling of kit boxes, and weighing kits per respective production procedures.

Physical Requirements

• Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility.
• Ability to inspect, analyze, and concentrate throughout the work shift.
• Fine manual dexterity to ensure precise assembly of medical devices.
• 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.
• Ability to wear all required personal protective equipment (lab coat, safety glasses, hair coverings, latex or nitrile gloves).
• Ability to identify and differentiate color and color changes on diagnostic devices and components.
• Ability to read, navigate, and operate control system screens and written documents throughout the workday.
• Ability to detect audible and/or visual alarms.

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 (email and Windows).
• Basic math skills and ability to perform step-by-step arithmetic calculations.
• Initiative, critical attention to detail, and organizational skills.
• Develop interpersonal, organizational, written, comprehension, and oral communication skills.
• Ability to maintain regular attendance and punctuality; must be able to work overtime and weekends to support production efforts as needed.
• Develop problem-solving and troubleshooting skills.