Weigh and Dispense Associate 3

Posted 2 days ago

fujifilmHolly Springs (NC)

SENIORITY

Mid

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About the role

Weigh And Dispense Associate The Weigh And Dispense Associate position is responsible for assisting with and executing the set-up, weighing of raw materials, solvents, and solutions used in GMP manufacturing at FDBN. This role interacts with manufacturing personnel in both Drug Substance and Drug Product teams as well as Warehouse for commercial operations and tech transfer activities required from the Weigh And Dispense operations. This role is responsible for weighing and dispensing in operations, plus duties to deliver goods to manufacturing, as needed. Additionally, there are interim responsibilities associated with a large greenfield start-up, including international travel, performing system user acceptance testing, and setting up the dispensary area for GMP operations. Night Shift- 6PM to 6:30AMSchedule- 2.2.3What You'll DoDuring Project Phase: Assists in the preparation for operational readiness related to weigh and dispense, including supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes, testing, commissioning support and assisting in the execution of validation protocols as required0-25% travel (international and/or domestic) may be required during project phase In Operations: Executes and documents weigh and dispense processing steps and/or weigh and dispense activities that include, but not limited to, use of benchtop or floor scales within a controlled environment, transport, and transfer of materials to manufacturing areas using powered industrial trucks Assembles and disassembles Intermediate Bulk Containers (IBC) for use and cleaning Operates GMP washers for Intermediate Bulk Containers (IBC), glassware and parts Utilizes Automated Weigh System/Syncade to dispense raw materials for processing Utilizes ERP system for ordering and receiving materials from the warehouse Executes cycle counting and troubleshoots inventory discrepancies, as needed Attends trainings and maintains proficiency to perform all required manufacturing related activities Trains associates on weigh & dispense operations, as needed Perform other duties, as assigned
Knowledge & Skills:
  • Requires shift work (weekend, potential for nights, and on-call)
  • Ability to assist in troubleshooting
  • Basic understanding of manufacturing run cadence and order of shift activities
  • Knowledgeable in cGMP, safety and FDBN operational procedures
  • Materials management
  • Ability to assist with all daily operations
Required Skills: High School Diploma or GED4 years of related experience in a manufacturing environment
Preferred Skills: Associate's Degree and 2+ years of direct experience in cGMP manufacturing environment OR BA / BS, preferably Life Sciences or Engineering OR Equivalent Military experience/training Internal or after training: Qualified on unit operation Working Conditions & Physical Requirements:
  • Physical Demands
  • Ability to ascend or descend ladders, scaffolding, ramps, etc.
  • Ability to stand for prolonged periods of timeAbility to sit for prolonged periods of timeAbility to conduct activities using repetitive motions that include writs, hands and/or fingers
  • Ability to operate machinery and/or power tools
  • Ability to conduct work that includes moving objects up to 10 lbs. to 33 lbs.
  • Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions
  • Environmental Conditions
  • Will work in warm/cold environments
  • Will work in outdoor elements such as precipitation and wind
  • Will work in small and/or enclosed spaces
  • Will work in heights greater than 4 feet

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