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Production Assembler
2 months ago
The Production Assembler position at Meridian Bioscience is a key role in our manufacturing team. As an Assembler, you will be responsible for safely assembling, manufacturing, and packaging regulated medical devices and kits in a performance-driven environment.
Key Responsibilities:- Quality and Safety: Maintain a safe work environment by complying with all safety and environmental policies, including the use of personal protective equipment (PPE).
- Equipment Operation: Learn to operate and maintain automated production equipment with direct supervision of a trained operator or higher.
- Assembly and Packaging: Perform manual and automated assembly/packaging of commercial diagnostic products and kits.
- Documentation: Complete daily documentation required for production procedures and supplemental documentation as needed.
- Inventory Management: Monitor inventory for the purpose of fulfilling daily production needs.
- Quality Control: Identify and communicate any abnormal components and deviating events to the Group Leader/Supervisor/Manager.
- 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.
- Learn how to and become proficient in machine setup, machine operation, card inspection, and preventative maintenance.
- Learn how to assemble FID plates into the final packaging.
- Learn how to calibrate and operate single-channel pipettes.
- 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.
- 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-channel pipettes.
- Learn how to initiate and complete KPRs.
- 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.
- 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.