Assembler

Assembler Position

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

Tasks/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 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 control 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.

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