UNION Packaging Operator LGMon - Thur - 2nd shift PDW

UNION Packaging Operator LG4 Mon - Thur 3:00pm - 1:30am 2nd shift PDW Description

To perform duties in the manufacturing and packaging of high quality biological products.

• Prepare, review and audit for completion and accuracy all assigned records, calibration, and documentation in assigned area to ensure regulatory compliance is maintained.
• Read and follow schedules, procedures, and documents.
• Assist in training other employees in an area of responsibility as assigned.
• Assist staff in developing new procedures and methods or improving old ones.
• Use and understand computer assisted data entry, including SAP, and process logic controllers (PLCs).
• Assist lower labor grades as needed to insure the completion of daily tasks.
• Assist validation group perform department equipment validations needed
• Ensure the availability of all items required to maintain schedules, procedures, and documentation.
• Perform housekeeping and safety inspections and issue reports of said inspections.
• Evaluate and recommend to management resource allocation needs, such as but not limited to, equipment allocations, supplies allocations, materials allocations, labor allocations.
• Assist staff in the transfer of new products, new test methods, new production processes, and new technology.
• Lead work teams to ensure completion of daily tasks.
• Assist in troubleshooting and improve packaging processes.
• Plan, perform, and monitor all packaging processes.
• Start-up, operate, monitor, maintain, and troubleshoot all production equipment, including automated packaging equipment, in assigned department.
• Interpret all process indicators, controls, and PLC controllers in assigned department.
• Evaluate equipment and facilities for the purpose of developing suggestions for improvements and/or corrective actions.
• Work effectively with outside consultants and service technicians.
• Perform final product quality inspections.
• Perform line audit to insure proper material usage.
• Prepare all assigned production records and documentation.
• Perform packaging assembly without mix-up or omission of components.
• Clean and organize production rooms.
• Monitor product storage criteria and maintain proper temperature.
• Assist with review and gathering data, analyze data, and report trends to management.
• Assist with gathering data or information for out-of-specification or deviation investigations.
• Maintain safe behavior practices.
• Meet production standards.
• Required to perform work of a lower classification as needed.
• All personnel will be required to routinely go through an aseptic qualification program to ensure adequate aseptic techniques and behavior.
• Other duties as assigned

• Education and/or Experience
  • High school diploma or equivalent
• Communication Skills
  • Good verbal and written communication skills and ability to train others.
  • Ability to work in a team environment
• Mathematical Skills
  • Perform calculations and conversions involving weights, volumes, and percentages.
• Reasoning Ability
  • Ability to use basic logic to identify and solve problems
  • Knowledge and skill to recognize creative ideas that add value and are able to be implemented to improve efficiency, effectiveness and reduce complexity for department
• Mechanical Aptitude
  • Demonstrated understanding of systems, equipment, and processes
  • Forklift certified and able to maintain annual certification
• Computer Skills
  • Experience with Windows Operating System.
  • Proficient in typing ability
• Comprehension and application
  • Proficient reading, comprehension and application skills toward a diverse set complicated tasks.
  • Ability to read small type (4 point).
  • Must have 20/30 corrected vision, color, and peripheral.
• Physical Demands
  • Ability to meet physical exertion requirements of job, to include lifting and push/pull of up to 50 pounds force.
  • Lifting, push/pull in this dept. does not exceed 50 pounds of force.
  • Labels, inserts, and displays are handled ranging from 14 to 48.5 pounds.
  • Full pallets of vaccine diluent, etc. are dealt w/using a hand jack (forces to push/pull these items range from 30-40 pounds of force).
  • Only item in the department weighing more than 50 pounds is a full box of paper, weighing 52 pounds, full box is not to be carried.
  • Box of paper should be opened and individual reams of paper taken out in stacks.
  • Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly.

• Additional Education and/or Equivalent Experience
• Successful completion of National Career Readiness Work Keys assessment
• Knowledge of Hazardous Waste Handling
• Knowledge of Traffic Patterns
• Knowledge of or evidence of working with BPE methods
• Understanding of Basic GMP/Documentation practices
• Demonstrated ability and understanding of Safe working habits including Material Safety Data Sheets (MSDS)
• Ability to work in a team environment.
• Demonstrated knowledge of Federal, State, and International regulations, such as cGMP, USDA, DOT, EPA, OSHA as they…