Quality Operations Specialist

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.
• Coordinate shipments of commercial, non-commercial and clinical goods, and as required, internal shipment requests.
• 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
• Strong negotiating skills and problem-solving abilities
• Effective oral and written communication skills including 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/Skills :

• Bachelor’s degree in science or a related field preferred.
• Targeting 3-5 years of experience in GMP pharmaceutical logistics and/or supply chain materials management. An equivalent combination of relevant education and experience may be considered.