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Quality Operations Specialist
Quality Operations SpecialistAequor • San Diego, CA, United States
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Quality Operations Specialist

Quality Operations Specialist

Aequor • San Diego, CA, United States
13 days ago
Job type
  • Full-time
Job description

Our client, a Biopharmaceutical Company with a focus on CNS and Neurology, is seeking a Quality Operations Specialist to join their team on a 1-year contract (20 hours per week) in San Diego, CA.

Responsibilities :

  • Overseeing / managing the Translational Sciences API inventory, requisition, and provisioning process; in addition to managing the GMP commercial reference standards.
  • Manage the active pharmaceutical ingredient inventory, requisition, and provisioning process for Quality Control; as well as GMP reference standards.
  • Track, manage, and communicate all logistics activities for Translational Sciences inventory as well as commercial reference standards.
  • Support commercial and non-commercial GMP and non-GMP logistics and supply operation and shipment activities.
  • Coordinate key development material shipments with managed carriers utilizing existing business processes, carrier portals and supply chain tools. Create shipping documents, customs invoices and other required logistics documents.
  • Support identification and management of domestic and international contract storage warehouses for commercial and clinical materials.
  • Tracking and updating shipments utilizing Smartsheet and other business tools and following up with vendors to complete chain of custody paper works for shipments.

Key Skills :

  • Demonstrated experience developing with GMP logistics operations, systems and procedures preferably with a virtual pharmaceutical company
  • Experience in utilization of ERP based systems a plus
  • Experience with GMP and temperature sensitive products
  • Strong analytical and computer skills required.
  • Proficient in MS office tools including Powe Bi, Adobe functions and Smartsheet a plus
  • Knowledge of CMO contract relationships, purchase orders and planning activities
  • Ability to write technical reports and communicate with senior management and subject matter experts (SMEs) as well as CMO supply chain, customs brokers, carriers agents and project management teams
  • Experience :

  • Bachelor’s degree in science or a related field preferred.
  • Targeting 5-10 years of experience in GMP pharmaceutical logistics and / or supply chain materials management.
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    Quality Specialist • San Diego, CA, United States

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