Overview
The Warehouse and Facility Specialist will be the main person managing the GMP warehouse in uBriGene Maryland and will participate in day-to-day operation activities. The role is expected to be an expert in WMS and to be familiar with GMP documentation. Â The role also assists the maintenance of facility and equipment.
Key Responsibilities
- Inventory Management: Keeping inventory of incoming materials and products; Managing quarantine, release and distribution of GMP materials; Documenting materials movement.
- WMS: Implementing, educating, and optimizing WMS operation in the company; Reviewing and maintaining the correctness and accuracy of entries.
- Facility: Helping day-to-day operation; providing technical service and support to all departments; Performing assigned facilities project work.
- Equipment: Maintaining accurate equipment records; Keeping calibration and PM schedules; Assisting equipment maintenance.
- Documentation: Keeping records; Authoring and/or contributing to the writing of SOPs, Corrective/Preventive Action initiatives, Change Control procedures, and technical protocols.
- Compliance: Ensure compliance with all cGMP, state and federal requirements and all applicable health and safety regulations (OSHA).
- Other duties as assigned by the Management Team.
- B.S. in a Science or Engineering discipline.
- Hands-on experience with materials and equipment management.
- Excellent communication skills, both oral and written.
- Experience and understanding of regulatory requirements as pertain to a cGMP manufacturing facility.
- Experience with computerized and data managing systems.
- Experience with Cell and Gene Therapy.
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