Assembler

Assembler PositionThe 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 DutiesTasks/Duties/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.Other duties as required.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.Job-Specific Responsibilities (but not limited to):Para PakWhen 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 AssemblyWhen 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 proceduresLearn how to perform Leak Testing per the respective procedureWhen operating the IDS Robotic Cell Learn to inspect strips for acceptable/unacceptable materialLearn how to load strips onto the assembly dialWhen completing manual assembly Learn to inspect strips for acceptable/unacceptable materialLearn to assemble strips into the appropriate deviceLearn to inspect devices for acceptable/unacceptable materialPremier ProductionWhen in Plate Coating Learn how to operate, maintain and clean micro well plate coating and packaging room and equipmentLearn how to produce, package and label coated microwell platesLearn how to set up/assemble microwell plates for production runsLearn how to set up sealer for coated micro well platesLearn how to set up balancesLearn how to calibrate and operate single and multichannel pipettesDispensingWhen in Dispensing. Learn how to set up manual and automated dispensersLearn how to manually label and crimpLearn how to tip, stopper, and cap vialsLearn how to setup, operate, and be proficient on Accraply Labelling SystemLearn how to calibrate and operate balancesLearn how to setup and monitor clean roomLearn how to properly gown for dispensing clean roomFungalWhen 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 singleKit AssemblyWhen 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.QualificationsMinimum 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