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.