Assembler

Meridian Bioscience, Inc.•Billerica, MA

19h•Onsite

About The Position

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. They 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. 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.

Requirements

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.

Nice To Haves

High School Diploma or general education degree (GED) preferred.
Prior manufacturing and/or assembly experience preferred.
Prior experience in an FDA regulated production environment preferred.

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 diagnostic kits & sensors.
Read, understand, and comply with current Good Manufacturing Practices and Standard Operating Procedures.
Learn to operate 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, following GDP practices.
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.
Notify supervisor of any manufacturing material that may be running low.
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 and managing job benefits, such as time & attendance.
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.
Other duties as required.
Must be able to demonstrate cross-training ability as set forth by management.
Perform related duties, under general supervision, following clearly prescribed standard practices (Kit Assembly).
Operate shrink wrapper machine to wrap packages to obtain proper wrapping.
Perform inventory checks and pick parts from stock room for kitting operations according to job order.
Confirm lot number on each job with Quality Control, and process paperwork on each order/lot.
Inspect reagent tubes, capillaries, droppers, buttons and other associated kit components for shipments.
Assemble kits under supervision of operators or manager.
Under supervision of higher level operators run or assist in running automated equipment to produce kit components.
Label vials, take inventories, keep records, and perform related duties under general supervision, following clearly prescribed standard practices (Sensor Assembly).
Assemble product in accordance with written specifications and procedures, ensuring lot number conformity and other quality requirements are satisfied.
Move boxes of product in area, stock shelves with specified items, take inventories of all items in storage area and keep related records.
Confirm lot number on each job with Quality Control and process paperwork on each order/lot.
Provide Quality Control with samples of products for appropriate testing, etc.
Complete all required documentation following GDP guidelines (Analyzer Assembly & Test).
Perform a variety of assembly operations associated with instrument production, which include hand assembly of components onto printed circuit boards.
Perform critical cleaning procedures, mixing and injecting epoxy and testing equipment used in instrument production.
Able to follow direction of senior operators in work cell for instruction.