Assembler

Meridian Bioscience•Cincinnati, OH

About The Position

The Assembler learns 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. The role requires learning departmental equipment and processes, meeting quality standards, and complying with current Good Manufacturing Practices (cGMP), Standard Operating Procedures, and applicable safety, environmental, regulatory, and quality-system requirements. The employee completes production documentation, conducts in-process sampling or inspections, monitors inventory, reports abnormal components or deviations, and develops competence in multiple skills across two departments through cross-training as directed by management. Work is performed with attention from an operator or higher-level employee. Depending on department assignment, duties may include assembling and packaging diagnostic products and kits; operating, setting up, cleaning, and maintaining production machinery; inspecting components and finished goods; labeling and reconciling labels; calibrating equipment; conducting leak tests; preparing and monitoring clean rooms; and completing production and label documentation. The role may involve Para Pak, ImmunoCard Assembly, Premier Production, Dispensing, Fungal plate production, or Kit Assembly tasks. The position requires the ability to walk between locations and use stairs throughout a multi-location facility; stand or sit for extended periods; stoop, reach, bend, and push or pull carts and hand jacks; and lift supplies or finished products weighing up to 25–50 pounds. Employees must be able to concentrate, problem-solve, perform precise manual assembly, distinguish colors and color changes, read and operate controls screens and written documents, detect audible or visual alarms, and wear required personal protective equipment.

Requirements

High school diploma or GED required.
Computer literacy and skills, including email and Windows, required.
Basic math skills and ability to perform step-by-step arithmetic calculations.
Ability to learn and retain good documentation practices.
Initiative, attention to detail, and organization.
Ability to develop and use interpersonal, organizational, written, comprehension, and oral communication skills.
Ability to maintain regular attendance and punctuality.
Ability to develop problem-solving and troubleshooting skills.
Ability to walk up and down several flights of stairs during the workday in a multi-location facility.
Ability to inspect, analyze, concentrate, and problem-solve throughout the work shift.
Fine manual dexterity for precise medical-device assembly.
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 and stoop, reach, bend, and push or pull carts and hand jacks.
Ability to wear required PPE, including a lab coat, safety glasses, hair coverings, and latex or nitrile gloves.
Ability to identify and differentiate colors and color changes on diagnostic devices and components.
Ability to read, navigate, and operate control-system screens and written documents, and detect audible or visual alarms.
Ability to work overtime and weekends as needed.

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 and comply with safety and environmental policies, including required PPE use.
Learn departmental operations, equipment, and processes.
Perform manual and automated assembly and packaging of commercial diagnostic products and kits.
Read, understand, and comply with cGMP requirements and Standard Operating Procedures.
Learn to operate and maintain automated production equipment under direct supervision of a trained operator or higher-level employee.
Complete required daily production documentation and audit paperwork for accuracy, legibility, and completeness.
Comply with OSHA, FDA, ISO, quality-system, company, and departmental requirements.
Learn to perform calibrations and routine process monitoring as needed.
Conduct in-process sampling and inspections and document results according to procedure.
Monitor inventory to support daily production needs.
Identify and communicate abnormal components and deviating events to the Group Leader, Supervisor, or Manager.
Learn and use computer programs required for job tasks.
Work with other departments and employees as needed and accept instruction from higher-level positions.
Develop competence in multiple skills in two departments through cross-training as instructed by management.
In Para Pak, learn bagger stations; catch, inspect, and package reagents; complete case packaging; label cases; identify and reconcile labels; use parts lists and applicable documents; and operate the Macro Con labeling machine.
In Rixan Production, learn machine setup and operation, card inspection, and preventive maintenance; in Spotting/Blocking, perform routine pushing, catching, quality operations, and cleaning, and contribute to machine setup.
For lyophilizer operations, learn to clean and unload the lyophilizer.
For Campbell Wrapper/Bosch Poucher operations, set up equipment, inspect packages, and perform leak testing according to procedure.
For IDS Robotic Cell and manual assembly, inspect strips and load them onto the assembly dial or assemble them into devices, checking for acceptable and unacceptable material.
In Plate Coating, operate, maintain, and clean coating and packaging rooms and equipment; produce, package, and label coated microwell plates; prepare production runs and sealers; set up balances; and calibrate and operate pipettes.
In Dispensing, set up manual and automated dispensers; label and crimp; tip, stopper, and cap vials; operate the Accraply Labelling System and balances; monitor the clean room; and follow clean-room gowning procedures.
In FID Plate Production, set up, dispense, punch, inspect, and clean up, and assemble FID plates into final packaging.
In Kit Assembly, initiate and complete KPRs and label requests; set up and calibrate a bench-top scale; and assemble kits, including stuffing components, labeling kit boxes, and weighing kits according to production procedures.
Perform other duties as required.
Work overtime and weekends as needed to support production efforts.