Assembler

Meridian Bioscience, Inc.•Newtown, OH

About The Position

Meridian Bioscience is seeking an Assembler to learn and perform the safe assembly, manufacture, and packaging of regulated medical devices and diagnostic kits in a performance-driven production environment. The role operates under the supervision of higher-level operators, supervisors, and managers and requires learning and meeting quality standards and adhering to current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), and applicable company, regulatory, and departmental requirements. The employee performs manual and automated production tasks across departments, operates production equipment with direct supervision, completes and audits production documentation, conducts in-process sampling and inspections, monitors inventory, and communicates abnormal components or process deviations. Through cross-training, the employee must demonstrate competence in multiple skills across two departments, as assigned by management. Departmental assignments may include Para Pak, ImmunoCard Assembly, Premier Production, Dispensing, Fungal plate production, and Kit Assembly. The role requires the ability to perform precise assembly and inspection tasks, work with production equipment and documentation, and meet the physical demands of a multi-location manufacturing facility. Overtime and weekend work may be needed to support production.

Requirements

High school diploma or 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 maintain regular attendance and punctuality.
Ability to develop problem-solving and troubleshooting skills.
Ability to develop interpersonal, organizational, written, comprehension, and oral communication skills.
Ability to work overtime and weekends as needed to support production.
Ability to walk up and down several flights of stairs during the workday.
Ability to inspect, analyze, concentrate, and routinely problem-solve throughout the work shift.
Fine manual dexterity for precise medical-device assembly.
Ability to lift 25–50 pounds of supplies or finished product during the work shift.
Ability to stand and/or sit for extended periods and stoop, reach, bend, push, and 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.
Ability to detect audible and visual alarms.

Nice To Haves

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

Responsibilities

Maintain a safe work environment, follow safety and environmental policies, and use required personal protective equipment.
Learn departmental operations, equipment, and production processes.
Perform manual and automated assembly and packaging of commercial diagnostic products and kits.
Read and comply with current Good Manufacturing Practices, Standard Operating Procedures, and applicable OSHA, FDA, ISO, quality-system, company, and departmental requirements.
Learn to operate and maintain automated production equipment under the direct supervision of a trained operator or higher-level employee.
Complete required daily production documentation and audit paperwork for corrections, missing information, accuracy, and legibility.
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 process deviations to the Group Leader, Supervisor, or Manager.
Learn and use computer programs needed for job tasks.
Work with other departments and employees as required and accept instruction from higher-level positions.
Cross-train and demonstrate competence in multiple skills in two departments, as directed by management.
In Para Pak, learn bagger stations; inspect, catch, and package reagents; perform final case packaging; label cases; reconcile labels; interpret parts lists and applicable documents; identify abnormal components; and operate the Macro Con labeling machine.
In ImmunoCard Assembly, learn machine setup, operation, card inspection, preventive maintenance, spotting/blocking tasks, lyophilizer cleaning and unloading, wrapper and poucher setup, package inspection and leak testing, robotic-cell strip inspection and loading, and manual strip/device assembly and inspection.
In Premier Production plate coating, learn to operate, maintain, and clean coating and packaging equipment and rooms; produce, package, and label coated microwell plates; set up plates and sealers; set up balances; and calibrate and operate single- and multichannel pipettes.
In Dispensing, learn to set up manual and automated dispensers; label and crimp; tip, stopper, and cap vials; set up and operate the Accraply Labelling System; calibrate and operate balances; set up and monitor the clean room; and gown appropriately.
In FID Plate Production, learn setup, dispensing, punching, inspection, cleanup, and final packaging of FID plates, as well as calibration and operation of equipment as assigned.
In Kit Assembly, initiate and complete KPRs and label requests; set up and calibrate a bench-top scale; and assemble kits, including pre-assembly component stuffing, kit-box labeling, and weighing according to production procedures.
Perform other duties as required.