Job Details
Position Summary:
The Warehouse Supervisor will be responsible for day-to-day operations in a GMP Warehouse at the RTP CARsgen facility for clinical and commercial products. Additionally, this role is responsible for managing the warehouse team and ensure the department meets deliverables/metrics. 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 inventory management. This position interacts cross-functionally with Quality Assurance, Manufacturing, Regulatory, Quality Control, Supply Chain and Technical Operations.
Key Responsibilities:
Adhere to GMP requirements, biosafety related regulations, Quality Systems, and other regulations to ensure the timeliness, correctness, authenticity, integrity, and traceability of information and data during the receipt, storage, and distribution of materials and products, and ensure the consistency of accounts, materials, and inventory management.
Evaluate, pick, and replenish cleaning gowning materials daily.
Schedule and prioritize daily activities as needed.
Responsible for supervising warehouse personnel to strictly implement SMP/SOP s that meet GMP regulations.
Develop a training plan for the warehousing and logistics department and ensure that warehouse personnel receive corresponding training.
- Revise SOPs, FORMs, as needed. Coordinates with QA on warehouse-related deviations,
Investigations, change control and CAPAs assigned to Warehouse.
- Responsible for establishing processes and ledger management for cold chain inventory including the receipt, storage, and distribution of blood products and CAR-T materials.
- Complete other tasks assigned by line manager.
Requirements:
Bachelor s degree with 6+years of experience; or
Associate degree with 7+years warehouse experience, preferably in a pharmaceutical environment
Ability to effective use Microsoft program such as Word,Excel and Outlook.
Strong communication skills(e.g.,clear and concise),both written and verbal and a team player.
Experience with ERP,Veeva,MES a plus.
Experience in cGMP warehouse environment or Quality support of Warehouse Operations
Good decision making with strong judgment through collaboration and consideration of others point-of-view.
Understanding of cGMP for cell therapy warehouse.
Flexibility to work on any shift required to accommodate the business needs.