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 follows quality standards and current Good Manufacturing Practices (cGMP), and requires cross-training across departments to demonstrate competence in multiple skills in two departments. The employee works with manual and automated production processes and equipment, completes required production documentation, and escalates abnormal components or deviations to a group leader, supervisor, or manager. Department-specific work may include assembling and packaging diagnostic products; operating bagging, labeling, coating, dispensing, wrapping, robotic, and other production equipment; inspecting components and finished packages; performing routine maintenance, calibration, sampling, and process monitoring; and completing production and label documentation. Tasks vary by assignment and department, including Para Pak, ImmunoCard Assembly, Premier Production, Dispensing, Fungal Plate Production, and Kit Assembly. The role involves working in a multi-location facility and requires sustained attention and concentration, fine manual dexterity, the ability to use required personal protective equipment, and the physical ability to stand or sit for extended periods, move around the facility, and handle supplies or finished products weighing up to 25–50 pounds. Overtime and weekends may be required to support production efforts.

Requirements

High school diploma or general education degree (GED).
Computer literacy, including email and Windows.
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 develop problem-solving and troubleshooting skills.
Ability to inspect, analyze, and concentrate throughout the work shift, and to problem-solve routinely.
Fine manual dexterity for precise assembly of medical devices.
Ability to walk up and down several flights of stairs in a multi-location facility.
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 to stoop, reach, bend, and push or pull carts and hand jacks.
Ability to wear required personal protective equipment, 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 and/or visual alarms.
Ability to maintain regular attendance and punctuality.
Ability to work overtime and weekends as needed.

Nice To Haves

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

Responsibilities

Maintain a safe work environment and comply with safety and environmental policies, including wearing required personal protective equipment.
Learn departmental operations, equipment, and processes; operate and maintain automated production equipment under direct supervision of a trained operator or higher-level employee.
Perform manual and automated assembly and packaging of commercial diagnostic products and kits.
Follow current Good Manufacturing Practices, Standard Operating Procedures, and applicable OSHA, FDA, ISO, quality-system, company, and departmental requirements.
Complete daily production documentation and supplemental documentation; review paperwork for missing, incomplete, or incorrect information and ensure it is neat, accurate, and legible.
Learn and perform calibrations and routine process monitoring as needed; conduct in-process sampling or inspections and document results according to procedure.
Monitor inventory to support daily production needs and communicate abnormal components and deviating events to a group leader, supervisor, or manager.
Learn and use computer programs required for job tasks.
Work with other departments and employees as needed, accept instruction from higher-level positions, and cross-train to become competent in multiple skills across two departments.
Depending on assignment, operate production stations and equipment; inspect, assemble, label, package, and test products; set up equipment; perform cleaning and routine maintenance; and complete department-specific production records and procedures.
Maintain regular attendance and punctuality; work overtime and weekends as needed to support production.