Location: Bothell,WA, USA
Job Title: Material Handler Location: Bothell, WA**100% Onsite Schedule: - 5:00am - 5:30pm - Thurs - Sat, and every other Wednesday Top Skills: - Previous GMP Experience - Attention to Detail - Organizational Skills Knowledge, Skills, and Abilities • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing. • Experience in: o Distribution, receiving, temperature storage, issuance, and inventory control practices including cycle counting, and rejected/expired material disposition. o Understanding controlled temperature, humidity, and pest control monitoring for cGMP environments. o Transportation lanes and cold chain logistical movement of time critical and temperature sensitive biologics. o Freight forwarder and courier direct shipments and associated documentation requirements. DUTIES AND RESPONSIBILITIES: • Coordinates internal and external customer requests across multiple unit operations during their shift to include personnel, material, and logistical needs. • Working with production planning, the Sr. Manufacturing Associate, and other shift leads to establish daily unit operations schedule that includes people, product, and material flow across multiple shifts. • Completing and reviewing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. • Assisting in the training of staff who are less experienced to ensure they have the necessary technical skills and knowledge. • Initiation of company discrepancies/deviations for non-conforming materials and operational anomalies. • Assisting in setting up warehouse operations equipment/fixtures. Perform facility and equipment commissioning activities. • Reviewing Warehouse Operations procedures and providing input in ensuring documents are technically sound, promote effective and efficient operations, and comply with cGMP requirements. • Performing tasks in a manner that are consistent with departmental and corporate safety policies, quality systems and GMP requirements. • Coordination of tasks with staff working within Warehouse Operations. • Additional duties, tasks and responsibilities as assigned by management.