Quality Operations Specialist

Job Title: Quality Operations Specialist III

Duties: Responsible for 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 Company Quality Control; as well as GMP reference standards. He/she will coordinate and track logistics activities. Ensure up-to-date and accurate data to support shipment requirements.

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 Company 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 Company commercial, non-commercial and clinical goods, and as required, internal shipment requests.

Support identification and management of Company's domestic and international contract storage warehouse's for Company 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.

Skills: 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 Strong interpersonal skills with experience working with multiple contract service providers 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 Strong attention to detail, process oriented, organizational and Good Documentation Practices skills Ability to identify and understand what needs to be accomplished and able to drive activities independently 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 Ability to manage change in a dynamic environment Skilled at creating a team environment that supports a common vision and ability to work cross functionally within multi-departmental teams within and without the organization Proficiency at effectively prioritizing goals, assessing team capability, and coordinating resources to achieve those goals

Keywords:
Education: Education/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.