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

Description 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. Requirements High school diploma or GED required. Associate degree in Supply Chain, Logistics, Life Sciences, Biotechnology, or a related discipline preferred. Formal training or certification in GMP, GDP, inventory control, or regulated manufacturing operations strongly preferred. 5+ years of progressive experience in raw material kitting, weighing, dispensing, inventory control, or warehouse operations within a GMP-regulated pharmaceutical, biopharmaceutical, or CDMO environment. Demonstrated experience in raw material kitting, weighing, dispensing, and staging within a GMP regulated manufacturing or warehouse environment. Strong working knowledge of GMP regulations, SOP compliance, and documentation best practices in pharmaceutical or biopharmaceutical operations. Proficiency in verifying material status, including lot numbers, expiration dates, labeling accuracy, and review of Certificates of Analysis (CoA). Experience performing line clearance, material segregation, and contamination prevention activities in controlled environments. Ability to accurately complete batch records in real time, ensuring data integrity, traceability, and audit readiness. Hands on experience with ERP, MES, or WMS systems for inventory tracking, material movements, and transaction documentation. Familiarity with inventory management practices, including cycle counting, min/max levels, MRP concepts, and temperature controlled material handling. Knowledge of logistics and shipping requirements, including domestic and international shipments and applicable regulations (e.g., IATA, 49 CFR DOT). Strong attention to detail with the ability to identify discrepancies, deviations, or non conformances and elevate issues promptly. Effective time management and prioritization skills to support daily production schedules and material readiness. Ability to maintain accurate records and ensure compliance with internal controls, inventory integrity, and audit Ability to communicate clearly and professionally with manufacturing, quality, logistics, procurement, and supply chain teams to support operational needs and resolve issues. Capable of preparing and contributing to daily operational reports related to inventory status, productivity, and order fulfillment. Advanced hands-on experience supporting manufacturing operations, including material issuance, reconciliation, returns, and deviation support. Demonstrated expertise in GMP compliance, including real-time batch documentation, traceability, line clearance, and audit readiness. Proven experience handling raw materials, APIs, intermediates, and finished goods, including CoA review, lot control, and expiration management. Strong working knowledge of ERP, MES, and/or WMS systems, including inventory investigations, cycle counts, and discrepancy resolution. Experience managing temperature-controlled materials, monitoring alarms, and ensuring inventory integrity. Ability to act as a subject matter resource for kitting and materials operations, supporting training, process improvements, and cross-functional issue resolution. Experience coordinating domestic and international shipments, including regulated or temperature-sensitive materials, preferred. #J-18808-Ljbffr ZYLIDAC-BIO-LLC