Capital Associated Industries, Inc.
  • Durham, NC, USA
  • Full Time

CoImmune Inc. is a US company based in Durham North Carolina that was founded in 2019 based on its expertise in the development and manufacture of cell-based therapeutics to treat unmet medical needs including cancer, autoimmune and inflammatory diseases. CoImmune has a 20,000 sq. ft. cGMP manufacturing facility capable of supporting clinical studies from Phase I through Phase 3. The company is preparing to initiate its first Phase 2 clinical trial using a strategic combination of immune-oncology therapeutics. In addition to developing its own therapeutic pipeline, the company plans to use its excess cGMP manufacturing capacity to provide revenue-generating contract services for the manufacturing of third-party clinical stage cell-based products.

Scope:  The individual in this position will assist with  shipping/receiving activities in the Materials Management Department with a focus on clinical trial kit assembly, charging liquid nitrogen shippers, and purchase/receipt of non-lot controlled materials. The individual will be required to receive and issue materials to support Research, Manufacturing and Quality activities. Maintain a high degree of inventory accuracy via cycle count programs. The job requires adherence to all practices to carry out shipping/receiving functions in an FDA-regulated warehouse setting.  

Responsibilities:

  • Assist with the coordination of material flow between transportation companies, the Shipping/Receiving Department and all internal departments
  • Communicate and document activities between Manufacturing, Clinical, and Quality departments to ensure the movement of materials meets regulatory guidelines
  • Prepare shipping documents for routing, including bills of lading and billing documents for air transport, common carrier, and overnight shippers compliant with established regulations.
  • Keep an inventory of incoming and outbound shipments.
  • Make routing decisions regarding methods and courier schedules
  • Prepare packages for shipping and maintain necessary inventory of shipping supplies
  • Maintain contact with couriers to ensure timely pickups and deliveries
  • Utilize an Inventory Management System to ensure inventory is maintained to predetermined min/max levels established with each department
  • Reconcile Purchase Orders with Accounts Payable
  • Adhere to all applicable SOP's in order to maintain GMP compliance
  • Manage regulated quarantine inventory according to QA specifications including notification, record preparation, segregation, and disposition.
  • Adhere to safety rules and keep work area in a clean and orderly condition
  • Assist with completion of daily and weekly reports from inventory system data and by entering or retrieving data using Excel spreadsheets
  • Perform other miscellaneous duties as required

 Qualifications:

  • High school graduate or associate degree.
  • Minimum 2 years relevant experience in shipping and receiving with cGMP warehousing experience. 
  • DOT/IATA training on hazardous materials.
  • Fluent with Windows computer applications that involve entering and retrieving information from files and reports. Experience in using Excel and Word is required.
  • Must have initiative, high attention to detail, and the ability to multi-task
  • Strong organizational skills a must.
  • Must be able to communicate effectively with co-workers and be willing to collaborate closely with co-workers and other groups.
  • Ability and willingness to be regularly, predictably, and reliably at work

PHYSICAL DEMANDS:

Possess physical strength with ability to lift 40 pounds.  Stamina required to stand, walk, climb or step-up for long periods of time in a warehouse environment. 

Capital Associated Industries, Inc.
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