Warehouse Specialist II - Raw Material Kitting (2nd Shift)

Kitting Preparation and Material Readiness

• Review daily work orders and batch records to determine material requirements.
• Verify inventory levels to ensure all raw materials required for kitting are available and meet specifications.
• Inspect the kitting area to confirm cleanliness, organization, and GMP readiness.
• Ensure accurate and complete documentation for all inbound and outbound materials.
• Schedule and monitor order dispatch to meet production and delivery timelines.

Raw Material Retrieval and Verification

• Retrieve raw materials from storage using proper GMP-compliant handling techniques.
• Verify material status by checking lot numbers, expiration dates, and Certificates of Analysis (CoA).
• Conduct visual inspections to confirm packaging integrity and absence of contamination.

Kitting and Material Processing

• Weigh and dispense materials precisely according to batch record requirements.
• Label components accurately with lot numbers, weights, and all required identifiers.
• Assemble materials into production kits while maintaining proper segregation to prevent cross contamination.

Documentation and Compliance

• Complete batch records in real time, capturing weights, lot numbers, and operator initials.
• Record material movement in ERP/MES systems to maintain full traceability.
• Follow all applicable SOPs and GMP guidelines throughout operations.
• Perform thorough line clearance to remove residual materials from previous batches.
• Conduct environmental monitoring of temperature, humidity, and cleanliness.
• Report any deviations, discrepancies, or non conformances immediately.
• Post Kitting Activities
• Clean and sanitize the kitting area following GMP requirements.
• Return unused materials to storage or dispose of them per SOPs.
• Update logs and confirm all documentation is complete, accurate, and audit ready.

Warehouse, Inventory, and Logistics Operations

Inbound Material Handling

• Unload incoming shipments and inspect for damage, shortages, or quality issues.
• Ensure timely receipt and secure handling of critical and temperature sensitive materials.
• Maintain proper documentation for all inbound and outbound transactions.
• Update Warehouse Management Systems (WMS) with real time data.

Reporting, Communication, and Coordination

• Prepare daily operational reports covering productivity, inventory status, and order fulfillment.
• Communicate effectively with logistics, procurement, and supply chain teams to resolve operational issues.

Inventory Management & Compliance

• Manage inventory for raw materials, intermediates, and finished goods in alignment with GMP requirements.
• Coordinate replenishment with procurement or supply chain teams.
• Maintain accurate inventory records using SOPs, tracking systems, and ERP tools.
• Safeguard inventory integrity by validating temperature controlled storage and conducting routine cycle counts to support SOX compliance.
• Monitor temperature controlled storage systems, respond to alarms, and ensure secure material handling.
• Manage inventory using established methodologies such as cycle counting, min/max levels, and MRP.

Logistics & Distribution

• Coordinate efficient domestic and international shipments in accordance with IATA and 49 CFR DOT regulations.
• Review documentation, packaging, and distribution of materials to internal teams, external laboratories, clinical sites, and global subsidiaries.
• Identify cost saving opportunities and collaborate with vendors for optimized logistics and packaging solutions.