GMP/ Warehouse Logistics Associate II - CARsgen Therapeutics Corpora

Position Summary:

The Warehouse Logistics Associate will be responsible for day-to-day operations in a GMP Warehouse at the RTP CARsgen facility for clinical and commercial products. The candidate will need to have a strong knowledge of Quality Systems such as owning or approving investigations/deviations, Change Controls, and CAPA’s associated with raw materials and Logistics. This position interacts cross-functionally with Quality Assurance, Manufacturing, Quality Control, Supply Chain and MSAT.

Responsibilities：

• Receive and issue PBMC, Serum and CAR-T.
• Store and maintain inventory within designated temperature zones.
• Collaboration with clinical team on scheduling, receiving, storing, and shipping clinical materials, domestically and internationally.
• Create, develop, and revise SOPs for warehouse functions and other applicable areas.
• Serves as a hands-on resource in Logistics and Supply Chain, being able to communicate to other departments on Supply Chain processes and procedures.
• Support internal stakeholders in scheduling and tracking the shipment of patient materials and the clinical products.
• Assist the warehouse manager in collecting and organizing the shipping records and relevant shipping documents.
• Develop expert knowledge of the cell therapy supply chain and the temperature controls required to support various shipping temperatures including controlled room temperature, 2-8°C, -20°C, dry ice, and liquid nitrogen shipping requirements.
• Accurate documentation of activities in accordance with cGMPs.
• Adherence to all QMS, cGMP, SOP and EHS policies and procedures.
• Perform other duties as assigned by management.

Qualifications：

• High School Diploma or GED
• 3+ years of previous experience as a material handler, warehouse, distribution, etc., required
• 2 years of experience in the pharmaceutical/biotech industry preferred
• Required to lift and move material physically
• Required to work in ambient and cold room temperatures
• Experience in managing cold-chain logistics of biological materials is preferred
• Physical requirements include bending, standing for extended periods of time, and frequent lifting of a maximum of 50 pounds
• May require working weekends, holidays, and overtime
• Basic knowledge of cGMP requirements preferred
• Experience drafting and revising SOP’s and documentation work preferred
• Basic computer knowledge (email, MS Office)