Warehouse Specialist II - Raw Material Kitting (2nd Shift)
2 days ago
Emeryville
Job DescriptionDescription: 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., • 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)., • Weigh and dispense materials precisely according to batch record requirements., • Label components accurately with lot numbers, weights, and all required identifiers., • 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. 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., • Prepare daily operational reports covering productivity, inventory status, and order fulfillment., • 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., • 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 escalate 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.