Demo

Facility Support Specialist

SDI International
Chapel Hill, NC Full Time
POSTED ON 2/5/2025
AVAILABLE BEFORE 5/4/2025
  • Execute GMP cleaning of critical spaces in accordance with Standard Operating Procedures.
  • Execute emergency GMP cleaning of spaces that were identified to have had a contamination event or rooms that have gone out of temperature / humidity specification.
  • Ability to create and revise standard operating procedures.
  • Coordinate with 3rd Party Cleaning vendor and ensures cleanings are completed as required.
  • Inspect rooms on daily basis for cleaning needs, removal of trash, removal of dirty gowning and placed in appropriate bins.
  • Support facility activities such as equipment calibration coordinate QC GMP Equipment role to manage incoming vendors
  • Inventory management - tracking PAR levels, ensuring materials are available, build manufacturing kits
  • Receiving of material when needed
  • Participate in 5 hours of continuing education annually in cellular therapy or quality topics.
  • Responsibilities may be modified or added as needed and discussed with the Assistant Director of QA / QC and / or Associate Director of Quality and Facility Director.
  • Must Have

    • Ability to do receipt of packages and help support inventory
    • Knowledge of how to execute GMP Cleaning
    • Support facility by removing trash from clean room suites and keeping gowning stocked
    • Nice To Have

    • Knowledge around calibration and preventative maintenance of equipment
    • Technical Writing
    • Word and Excel

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