Material Handler

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.