GMP Logistics Specialist (Pharma/CDMO/CRO)
Job Title: GMP Logistics Specialist
Location: Onsite, Cranbury & South Plainfield, NJ
Position Type: Full-Time
Reports To: Manager, Operations
Job Summary:
We are seeking a highly motivated and experienced GMP Logistics Specialist to join our team within the Contract Development and Manufacturing Organization (CDMO) industry. The successful candidate will oversee logistics operations with a focus on inventory management, shipping, and regulatory compliance in a Good Manufacturing Practice (GMP) environment. This role requires a keen attention to detail, strong organizational skills, and the ability to collaborate with cross-functional teams to ensure seamless logistics operations that support the manufacturing process.
The GMP Logistics Specialist will play an essential role in maintaining the efficient flow of materials, meeting production demands, and ensuring all logistics activities are compliant with applicable regulatory standards, including safety and quality protocols.
Key Responsibilities:
Inventory and Stock Management:
• Oversee the receipt, storage, and movement of raw materials, consumables, and finished products to ensure compliance with GMP guidelines.
• Monitor inventory levels to ensure the availability of materials needed for production while minimizing excess stock and ensuring regulatory compliance.
• Conduct regular inventory audits and reconcile discrepancies between physical stock and system records.
• Maintain accurate and up-to-date records of inventory transactions using inventory management systems (e.g., barcode scanning, ERP systems).
Shipment and Order Management:
• Coordinate the receipt and shipment of materials in compliance with GMP and regulatory requirements.
• Ensure accurate order fulfillment by verifying shipment contents against purchase orders and ensuring timely deliveries.
• Review and manage shipping documentation, ensuring compliance with safety regulations, including DOT, IATA, and other relevant transportation laws.
• Facilitate shipments and deliveries while maintaining compliance with GMP, health, safety, and environmental guidelines.
Vendor and Supplier Coordination:
• Work closely with suppliers and vendors to ensure timely delivery of materials and consumables.
• Support procurement activities by assisting with supplier selection, contract negotiations, and ensuring that materials meet quality and regulatory standards.
• Communicate with suppliers regarding delivery schedules, material specifications, and inventory levels to ensure continuous material availability.
Regulatory Compliance and Safety:
• Ensure that all logistics activities are conducted in compliance with GMP, FDA, and other regulatory bodies, such as the Department of Transportation (DOT) and Environmental Protection Agency (EPA).
• Support the management of hazardous materials, ensuring proper labeling, handling, storage, and disposal in compliance with regulatory standards.
• Maintain a safe and compliant warehouse and storage environment, following all safety procedures for hazardous chemicals and materials.
Shipping and Receiving:
• Oversee the shipping and receiving process, ensuring that materials are properly handled, stored, and tracked throughout the process.
• Manage relationships with logistics providers to ensure timely and cost-effective shipments, keeping a close eye on shipping costs and tracking metrics.
• Ensure packaging materials are available for daily shipping operations and comply with regulatory standards for transport and storage.
Cross-Functional Collaboration:
• Collaborate with production, quality assurance, and procurement teams to ensure logistics operations align with production needs and timelines.
• Provide logistics-related support to cross-functional teams, including Site Administrators, Operations, and Management, ensuring smooth and efficient operations.
• Assist in troubleshooting and resolving logistics-related issues as they arise to prevent production delays.
Reporting and Documentation:
• Generate and maintain detailed reports on inventory levels, shipping activities, and logistics costs.
• Track and document logistics data in compliance with GMP documentation practices, ensuring proper records retention and easy retrieval for audits or regulatory inspections.
Training and Continuous Improvement:
• Maintain up-to-date knowledge of industry best practices and regulatory requirements.
• Participate in regular training on GMP, safety protocols, hazardous material handling, and other relevant certifications.
• Contribute to continuous improvement efforts by identifying opportunities to optimize logistics processes, reduce costs, and improve efficiency.
Qualifications:
• Education: High School diploma or Associate’s degree with relevant industry experience. Bachelor’s degree in Logistics, Supply Chain Management, Business Administration, or a related field. Certifications such as APICS, CLTD, or other logistics-related credentials are a plus.
• Experience: Minimum of 2-4 years of experience in logistics, inventory management, or supply chain roles, preferably in the pharmaceutical, biotechnology, or CDMO industries.
• Skills:
o Strong knowledge of GMP requirements and regulatory guidelines within a pharmaceutical or manufacturing environment.
o Proficient in logistics software and inventory management systems (ERP systems, barcode systems).
o Solid understanding of hazardous material handling, shipping regulations (DOT, IATA), and safety compliance.
o Excellent organizational, problem-solving, and time-management skills.
o Strong interpersonal and communication skills with the ability to collaborate cross-functionally and with external partners.
o Ability to manage multiple priorities and meet tight deadlines while maintaining accuracy.
Job Title: GMP Logistics Specialist
Location: Onsite, Cranbury & South Plainfield, NJ
Position Type: Full-Time
Reports To: Manager, Operations
Job Summary:
We are seeking a highly motivated and experienced GMP Logistics Specialist to join our team within the Contract Development and Manufacturing Organization (CDMO) industry. The successful candidate will oversee logistics operations with a focus on inventory management, shipping, and regulatory compliance in a Good Manufacturing Practice (GMP) environment. This role requires a keen attention to detail, strong organizational skills, and the ability to collaborate with cross-functional teams to ensure seamless logistics operations that support the manufacturing process.
The GMP Logistics Specialist will play an essential role in maintaining the efficient flow of materials, meeting production demands, and ensuring all logistics activities are compliant with applicable regulatory standards, including safety and quality protocols.
Key Responsibilities:
Inventory and Stock Management:
• Oversee the receipt, storage, and movement of raw materials, consumables, and finished products to ensure compliance with GMP guidelines.
• Monitor inventory levels to ensure the availability of materials needed for production while minimizing excess stock and ensuring regulatory compliance.
• Conduct regular inventory audits and reconcile discrepancies between physical stock and system records.
• Maintain accurate and up-to-date records of inventory transactions using inventory management systems (e.g., barcode scanning, ERP systems).
Shipment and Order Management:
• Coordinate the receipt and shipment of materials in compliance with GMP and regulatory requirements.
• Ensure accurate order fulfillment by verifying shipment contents against purchase orders and ensuring timely deliveries.
• Review and manage shipping documentation, ensuring compliance with safety regulations, including DOT, IATA, and other relevant transportation laws.
• Facilitate shipments and deliveries while maintaining compliance with GMP, health, safety, and environmental guidelines.
Vendor and Supplier Coordination:
• Work closely with suppliers and vendors to ensure timely delivery of materials and consumables.
• Support procurement activities by assisting with supplier selection, contract negotiations, and ensuring that materials meet quality and regulatory standards.
• Communicate with suppliers regarding delivery schedules, material specifications, and inventory levels to ensure continuous material availability.
Regulatory Compliance and Safety:
• Ensure that all logistics activities are conducted in compliance with GMP, FDA, and other regulatory bodies, such as the Department of Transportation (DOT) and Environmental Protection Agency (EPA).
• Support the management of hazardous materials, ensuring proper labeling, handling, storage, and disposal in compliance with regulatory standards.
• Maintain a safe and compliant warehouse and storage environment, following all safety procedures for hazardous chemicals and materials.
Shipping and Receiving:
• Oversee the shipping and receiving process, ensuring that materials are properly handled, stored, and tracked throughout the process.
• Manage relationships with logistics providers to ensure timely and cost-effective shipments, keeping a close eye on shipping costs and tracking metrics.
• Ensure packaging materials are available for daily shipping operations and comply with regulatory standards for transport and storage.
Cross-Functional Collaboration:
• Collaborate with production, quality assurance, and procurement teams to ensure logistics operations align with production needs and timelines.
• Provide logistics-related support to cross-functional teams, including Site Administrators, Operations, and Management, ensuring smooth and efficient operations.
• Assist in troubleshooting and resolving logistics-related issues as they arise to prevent production delays.
Reporting and Documentation:
• Generate and maintain detailed reports on inventory levels, shipping activities, and logistics costs.
• Track and document logistics data in compliance with GMP documentation practices, ensuring proper records retention and easy retrieval for audits or regulatory inspections.
Training and Continuous Improvement:
• Maintain up-to-date knowledge of industry best practices and regulatory requirements.
• Participate in regular training on GMP, safety protocols, hazardous material handling, and other relevant certifications.
• Contribute to continuous improvement efforts by identifying opportunities to optimize logistics processes, reduce costs, and improve efficiency.
Qualifications:
• Education: High School diploma or Associate’s degree with relevant industry experience. Bachelor’s degree in Logistics, Supply Chain Management, Business Administration, or a related field. Certifications such as APICS, CLTD, or other logistics-related credentials are a plus.
• Experience: Minimum of 2-4 years of experience in logistics, inventory management, or supply chain roles, preferably in the pharmaceutical, biotechnology, or CDMO industries.
• Skills:
o Strong knowledge of GMP requirements and regulatory guidelines within a pharmaceutical or manufacturing environment.
o Proficient in logistics software and inventory management systems (ERP systems, barcode systems).
o Solid understanding of hazardous material handling, shipping regulations (DOT, IATA), and safety compliance.
o Excellent organizational, problem-solving, and time-management skills.
o Strong interpersonal and communication skills with the ability to collaborate cross-functionally and with external partners.
o Ability to manage multiple priorities and meet tight deadlines while maintaining accuracy.