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Skills
Calibrationunmatched
Change Controlunmatched
Communication Skillsunmatched
Corrective Actionunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Documentationunmatched
Equipment Maintenance/Repairunmatched
Facilities and Maintenanceunmatched
GMP (Good Manufacturing Practices)unmatched
Gene Therapyunmatched
Inventory Managementunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Materials Managementunmatched
OSHAunmatched
Presentation/Verbal Skillsunmatched
Record Keepingunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Release Management/Engineeringunmatched
Safety/Work Safetyunmatched
Standard Operating Procedures (SOP)unmatched
Systems Administration/Managementunmatched
Technical Supportunmatched
Warehousingunmatched
Writing Skillsunmatched
Description
Title: Warehouse and Facility Specialist 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. 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.
Qualifications and Experience
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.