Cell Biology, Commissioning, Corporate Policies, Current Good Manufacturing Practice (cGMP), Detail Oriented, Documentation, Documentation Review, Environmental Monitoring, FDA Requirements, Freight Forwarding, GMP (Good Manufacturing Practices), Inventory Management, Manufacturing, Operational Audit, Operations, Operations Management, Operations Processes, Organizational Skills, Pest Control, Product Flow, Production Planning, Quality System Requirements (QSR), Safety/Work Safety, Shipping/Receiving, Staff Training, Standard Operating Procedures (SOP), Technical Writing, Validation Plan, Warehousing
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.