Materials Management Associate II

DUTIES AND RESPONSIBILITIES

• Perform materials management activities with cGMP compliance and support regulatory audit readiness.
• Perform hands-on materials management operations including receiving, inspecting, dispositioning, replenishing and shipping of controlled materials and supplies for cGMP manufacturing of cell and gene therapy products.
• Receive and inspect incoming materials to ensure shipment integrity, accurate quantities, proper documentation and labeling, and compliance with purchase-order accuracy.
• Investigate inventory discrepancies, temperature excursions, damaged shipments, and material-related deviations.
• Support change controls, CAPAs, deviations, supplier qualification, and risk assessments.
• Work with Manufacturing, Quality Control, and Quality Assurance teams and inventory systems to ensure adequate materials are available and released in time to support GMP production.
• Cook up and/or update raw material/supplies specification as well as develop or modify SOPs for material management processes, as necessary.
• Organize storage rooms, perform cycle counts, data entry to maintain a cGMP inventory system thus ensuring all our departments have adequate access to the materials they need.
• Disposition of all expired materials and maintain applicable documentation.
• Maintain temperature conditions of refrigerators, freezers, and room temperature storage of cGMP materials.
• Cook up sampling, testing, release, and disposition with Quality Assurance and Quality Control.

EDUCATION AND EXPERIENCE

• Associate or bachelor’s degree in life science or supply chain management, or equivalent combination of education and experience.
• Minimum of 4 years’ experience in a regulated materials management environment.
• Knowledge of principles and practices of current Good Manufacturing Practices (cGMPs).
• Working knowledge of GMP/GDP, material traceability, data integrity, and warehouse controls.
• Experience in biotechnology, biopharmaceutical, pharmaceutical, or another regulated industry.
• Strong computer skills with Microsoft Office and the ability to quickly learn new applications.
• Experience with Inventory Management Systems/ERP and OE/5S is a plus.

DESIRE KEY COMPETENCIES

• Comfortable in a fast-paced company environment and able to change direction easily to accommodate the situation at hand, while maintaining a positive attitude.
• Self-organizer, meticulous hands-on habits, keen attention to detail.
• Highly motivated with excellent interpersonal, collaborative, and team-oriented skills to work well with the rest of the organization and build relationships with suppliers.
• Perform other responsibilities to support the needs of the department, as assigned.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Strong quantitative and analytical skills.
• Able to understand and execute the company’s mission and values.
• Maintain a high degree of ethical standards and trustworthiness.
• Exhibits and open mindset when approaching challenges and conflict.
• Able to think and adapt to a rapidly changing environment and demands.