GMP Shipping Assistant (Temp to Perm)

Our client here in Boston, MA is looking to hire a GMP Shipping Assistant to their Technical Operations team (Temp to Perm, onsite)!  This role will be responsible for manufacturing compliance, shipments, and systems. The individual will have familiarity with GMP production or supply chain, technical writing skill sets, ability to generate internal impact assessments, lead investigations, and be capable of working independently with minimal supervision. Experience in collaborating between cross functional departments in an external manufacturing setting is a plus.  

Responsibilities:

  • Manage all technical operations related shipments (i.e. Stability samples, etc.) in accordance with standard operating procedures (SOPs), approximately 25 shipments per quarter or 100 shipments per calendar year.
  • Directly interact with shipping courier(s) (i.e. QuickSTAT, World Courier, etc.) to place and schedule sample shipment orders.
  • Directly interact with shipping courier contract manufacturing organizations for sample shipment paperwork and deliveries.
  • Directly interact with shipping courier contract testing laboratories for sample shipment paperwork and sample receipt.
  • Investigate shipping related quality events and deviations working with vendors and suppliers.
  • Prior experience in GMP manufacturing, supply chain and/or shipping.
  • Ability to technical write (SOPs, Deviations, Investigations, etc.).
  • Experience working with external manufacturing cross functional teams is a plus (Tech Ops, QA, QC, Supply Chain, etc.).

Requirements:

  • Bachelor’s degree with 1-2 years GMP experience.
  • Prefer Boston local candidates to be on-site 3-4 days per week.
  • Manual dexterity required to operate office equipment (e.g. computers, phones, etc.).
  • Typical office and laboratory bending, stooping, and lifting requirements.
  • Willingness to travel to various meetings or client sites, including overnight trips (up to 10%).