GMP Material Specialist, Senior

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

JOB SUMMARY 

The GMP Materials Specialist, Senior will work collaboratively with others, performing various Good Manufacturing Practices (GMP) Warehouse processes. The ideal candidate possesses strong multi-tasking skills, strong verbal and written communication skills, and experience working in a fast-paced, dynamic environment with limited supervision. Provides exceptional customer service to our customers internal and external. 

ESSENTIAL JOB DUTIES/RESPONSIBILITIES 

• Assist supervisor with training personnel and creation of job aids for warehouse and materials management functions, ERP functions. 

• Perform timely and accurate transactions in ERP and related inventory/data management systems. Ability to perform all functions as primary receiver or shipper. 

• Support monitoring, ordering, and handling of supplies and materials used in facilities and manufacturing operations. Dispenses materials to support manufacturing. Includes handling hazardous materials, detailed measurement/portioning, performing aseptic technique in a clean room setting. 

• Help organize and clean warehouse, ensures material identification, status, location, movement, and quantities are accurate, timely and correct. 

• Identify opportunities for process improvement related to warehouse operations, processes, and procedures, to produce reduction of labor, or improvement in quality or accuracy. 

• Conduct cycle counts, inventory/discrepancy research and coordinates year end physical count. 

• Understand and adhere to SOPs and cGMP compliance regarding materials control in multiple storage locations and conditions. Understands rules and regulations on hazmat shipping domestically and internationally, as well as procedures and shipping requirements for safe transit of high value materials via parcel or freight. 

• Focus on receiving, packing and shipping of biologics and hazardous goods. 

• Participate in the creation and maintenance of job aids, training materials, and qualification processes, deviation/CAPA/CR’s. Ability to initiate Deviation/CAPA and Change Request as needed. 

• Ensures warehouse safety standards are upheld, and notifies management staff of any issues, observations, or concerns regarding violations, or potential enhancements to department safety. Ability to generate Job Safety Analysis suggestions. 

SKILLS 

• Ability to communicate clearly and interact constructively with peers and other departments. 

QUALIFICATIONS  

Required: 

• A minimum of 8+ years of experience in materials management or inventory control positions in cGMP environment and at least 8 years’ experience handling and transacting lot-controlled inventory (preferably in a GMP environment). 

• Extended use and experience with ERP, MRP and inventory management systems. 

• Ability to handle key inventory item processing; API, Cell Banks, Vial Pulls. 

• Ability to regularly generate process and initiate improvement suggestions to support key initiatives proposed by management.