Assembler

Meridian Bioscience, Inc.•Newtown, OH

10d

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 is responsible for meeting quality standards and following current Good Manufacturing Practices (cGMP), Standard Operating Procedures, and applicable safety, environmental, regulatory, and company requirements. The employee receives direct supervision when learning to operate and maintain automated production equipment and is expected to develop competence in multiple skills across two departments through management-directed cross-training. Responsibilities may vary across Para Pak, ImmunoCard Assembly, Premier Production, Dispensing, Fungal production, and Kit Assembly. Tasks can include manual and automated assembly and packaging, equipment setup and operation, inspection and in-process sampling, labeling, calibration, routine maintenance and cleaning, production documentation, inventory monitoring, and identifying and reporting abnormal components or process deviations. The role requires using production documentation and computer programs, maintaining accurate records, and working with other employees and departments as needed. Operator or higher-level employee attention is required at this level. The position involves physical activity throughout the workday, including walking between locations, standing or sitting for extended periods, lifting supplies or finished products, and performing precise manual assembly. Required PPE must be worn. The employee must be able to inspect and distinguish color changes, read documents and control screens, and detect audible or visual alarms.

Requirements

High school diploma or GED required.
Computer literacy, including email and Windows skills.
Basic math skills and ability to perform step-by-step arithmetic calculations.
Ability to learn and retain good documentation practices.
Initiative, critical attention to detail, and organizational skills.
Ability to develop and use interpersonal, organizational, written, comprehension, and oral communication skills.
Ability to maintain regular attendance and punctuality.
Ability to work overtime and weekends as needed to support production.
Ability to develop problem-solving and troubleshooting skills.
Ability to walk up and down several flights of stairs during the workday.
Ability to inspect, analyze, and concentrate throughout the work shift, and to problem-solve routinely.
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 or sit for long periods and to 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 throughout the workday.
Ability to detect audible and/or 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 and comply with safety and environmental policies, including the use of required PPE.
Learn departmental operations, equipment, and processes.
Perform manual and automated assembly and packaging of commercial diagnostic products and kits.
Read, understand, and follow current Good Manufacturing Practices 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 supplemental documentation; check records for accuracy, completeness, and legibility.
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 or inspections and document results according to procedure.
Monitor inventory to support daily production needs.
Identify and communicate abnormal components and deviations to the Group Leader, Supervisor, or Manager.
Learn and use computer programs required for job tasks.
Work with other departments and employees as required and accept instruction from higher-level positions.
Develop competence in multiple skills across two departments through management-directed cross-training.
Learn assigned production tasks across Para Pak, ImmunoCard Assembly, Premier Production, Dispensing, Fungal production, and Kit Assembly, including equipment setup and operation, inspection, packaging, labeling, cleaning, calibration, and assembly.
Perform other duties as required.