Meridian Bioscience

Develops and distributes diagnostic test kits

Assembler

Product AssemblyConfirmed live in the last 24 hours

Full-timeCincinnati, OH, USANo salary listedIn-person

About the Job

Requirements

A high school diploma or general education degree (GED) is required.
Computer literacy, including email and Windows, is required.
Basic math skills and the ability to perform step-by-step arithmetic calculations are required.
The employee must be able to work overtime and weekends as needed to support production.
The employee must be able to walk up and down several flights of stairs; inspect, analyze, and concentrate throughout a shift; problem solve routinely; and maintain fine manual dexterity for precise assembly.
The employee must be able to lift 25–50 pounds and stand or sit for long periods, stoop, reach, bend, and push and pull carts and hand jacks.
The employee must be able to wear required personal protective equipment, including a lab coat, safety glasses, hair coverings, and latex or nitrile gloves.
The employee must be able to identify and differentiate colors and color changes on diagnostic devices and components; read, navigate, and operate control-system screens and written documents; and detect audible or visual alarms.
The employee must maintain regular attendance and punctuality.

Responsibilities

Maintain a safe work environment by complying with safety and environmental policies, including using personal protective equipment.
Learn departmental operations, equipment, and processes, and safely perform manual and automated assembly and packaging of commercial diagnostic products and kits.
Read, understand, 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 production procedure documentation and supplemental documentation as needed; audit paperwork for corrections, missing information, and completeness, and ensure it is neat, accurate, and legible.
Learn to perform calibrations and routine process monitoring; conduct in-process sampling or inspections and document them according to procedure.
Monitor inventory to fulfill daily production needs and report abnormal components or deviating events to the Group Leader, Supervisor, or Manager.
Learn and use the computer programs required for job tasks; work with other departments and employees as required and accept instruction from higher-level positions.
Demonstrate competency in multiple skills across two departments through cross-training as instructed by management; perform other duties as required.
In Para Pak, learn to identify abnormal and out-of-specification components; work all bagger stations; catch, inspect, and package reagents; complete final case packaging; label inner and outer cases; identify labels using the correct documentation; complete label reconciliation; read and understand the Parts List for each order and applicable SP and EP documents; and operate the Macro Con labeling machine.
In Rixan Production, learn machine setup and operation, card inspection, and preventative maintenance.
In Spotting/Blocking, learn and perform routine pushing, catching, quality operations, and cleaning, and contribute to machine setup.
When operating lyophilizers for vacuum drying, learn to clean and unload a lyophilizer.
When operating the Campbell Wrapper/Bosch Poucher, set up the equipment, inspect packages according to procedures, and perform leak testing according to procedure.
In the IDS Robotic Cell, inspect strips for acceptable or unacceptable material and load strips onto the assembly dial.
During manual assembly, inspect strips and devices for acceptable or unacceptable material and assemble strips into the appropriate device.
In Plate Coating, operate, maintain, and clean microwell plate coating and packaging rooms and equipment; produce, package, and label coated microwell plates; set up and assemble plates for production runs; set up the sealer; set up balances; and calibrate and operate single- and multichannel pipettes.
In Dispensing, set up manual and automated dispensers; manually 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 for the dispensing clean room.
In FID Plate Production, set up, dispense, punch, inspect, and clean up; assemble FID plates into final packaging; and calibrate and operate single pipettes.
In Kit Assembly, initiate and complete KPRs and label requests; set up and calibrate a benchtop scale; and assemble kits, including stuffing components, labeling kit boxes, and weighing kits according to production procedures.

Desired Qualifications

Prior manufacturing or assembly experience is preferred.
Prior experience in an FDA-regulated production environment is preferred.

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

The Assembler position requires the employee to learn how to safely assemble, manufacture, and package regulated medical devices and kits in a performance driven environment under the supervision of higher-level operators / Supervisors / Managers. The employee will work to understand and meet all quality standards and adhere to all cGMP standards.

Key Duties

Major Duties and Responsibilities:

Maintain a safe work environment by complying with all safety and environmental policies including the use of PPE.
Expand upon limited knowledge of departmental operations to understand the equipment and processes.
Perform manual and automated assembly/packaging of commercial diagnostic products and kits.
Read, understand, and comply with current Good Manufacturing Practices and Standard Operating Procedures.
Learn to operate and maintain automated production equipment with direct supervision of a trained operator or higher.
Complete daily documentation required for production procedures and supplemental documentation as needed.
Audit own paperwork for corrections, missing, and/or incomplete information ensuring that it is neat, accurate, and legible.
Comply with all OSHA, FDA, ISO, Quality system, Company and departmental requirements.
Learn to perform calibrations and routine process monitoring as needed.
Conduct in process sampling and/or inspections and document per procedure.
Monitor inventory for the purpose of fulfilling daily production needs.
Identify and communicate any / all abnormal components and deviating events to the Group Leader/Supervisor/Manager.
Learn to use necessary computer programs for the required job tasks.
Demonstrate willingness to work with other departments and employees as required and accept instruction from higher level positions.
Operator or higher-level employee attention is required at this level.
Must be able to demonstrate/ be competent in multiple skills in 2 departments, listed within the Job Specific responsibilities above, through cross-training over several departments as instructed by management.
Other duties as required.

Job-Specific Responsibilities (but not limited to):

Para Pak

When in Para Pak
- 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.

ImmunoCard Assembly

When in Rixan Production
- Learn how to and become proficient in machine setup, machine operation, card inspection, and preventative maintenance.
When in Spotting/Blocking
- Learn and become proficient in the routine tasks of pushing, catching, quality operations, and cleaning.
- Contribute to the machine setup.
When operating the Lyophilizers to Vacuum Dry
- Learn how to clean and unload a lyophilizer.
When operating the Campbell Wrapper/Bosch Poucher
- Learn how to set up the assets
- Learn how to inspect packages per the respective procedures
- Learn how to perform Leak Testing per the respective procedure
When operating the IDS Robotic Cell
- Learn to inspect strips for acceptable/unacceptable material
- Learn how to load strips onto the assembly dial
When completing manual assembly
- Learn to inspect strips for acceptable/unacceptable material
- Learn to assemble strips into the appropriate device
- Learn to inspect devices for acceptable/unacceptable material

Premier Production

When in Plate Coating
- Learn how to operate, maintain and clean micro well plate coating and packaging room and equipment
- Learn how to produce, package and label coated microwell plates
- Learn how to set up/assemble microwell plates for production runs
- Learn how to set up sealer for coated micro well plates
- Learn how to set up balances
- Learn how to calibrate and operate single and multichannel pipettes

Dispensing

When in Dispensing.
- 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

Fungal

When in FID Plate Production
- 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

Kit Assembly

When in Kit Assembly
- Learn how to initiate and complete KPR’s.
- Learn how to initiate and complete label requests.
- Learn how 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.

Other Duties/Physical Requirements

Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility.
Must have the ability to inspect, analyze and concentrate throughout the course of the work shift.
Must be able to concentrate and problem solve routinely throughout the course of the work shift.
Must have fine manual dexterity to ensure precise assembly of medical devices.
Must have the 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, stoop, reach, bend, push and pull carts and hand jacks throughout the course of the work shift.
Ability to wear all required personal protective equipment (lab coat, safety glasses, hair coverings, latex or nitrile gloves)
Must be able to identify and differentiate color and color changes on diagnostic devices and device components.
Must be able to read, navigate, and operate controls systems screens and written documents throughout the course of the workday.
Must be able to detect audible and or visual alarms.

Qualifications

Minimum Education or Equivalent Experience Required/Preferred:

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.

Competencies Required or 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.

Required Travel

None

*We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing. (USA Only)*

About the Company

Meridian Bioscience

Develops and distributes diagnostic test kits

Meridian Bioscience develops, manufactures, markets and distributes diagnostic test kits, rare reagents, specialty biologicals and components for life science and agri-bio research. Its diagnostic tests are designed for use outside the body with minimal equipment, delivering fast, accurate results to support early diagnosis and treatment of infections and lead exposure. The company operates an end-to-end platform from development to distribution and holds strong positions in gastrointestinal and upper respiratory infections as well as blood lead level testing, while also supplying components used by others to build diagnostics. Its goal is to improve patient well-being and reduce health care costs by making diagnostic solutions and research materials accessible worldwide.

Company size: 501-1,000
Company stage: IPO
Headquarters: Newtown, OH
Founded: 1977

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