Materials Management Associate II

The position is responsible for all aspects of materials management and materials flow focused on cGMP operations, while maintaining control and accuracy over all inventory, material movements, and compliant records.

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.
• Coordinate and ship products, samples, and ensure temperature sensitive material reaches their destinations on time and in full.
• Create 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.
• Perform disposition of all expired materials and maintain applicable documentation.
• Monitor temperature conditions of refrigerators, freezers, and room temperature storage of cGMP materials.
• Coordinate sampling, testing, release, and disposition with Quality Assurance and Quality Control.
• Other duties as assigned.

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.

DESIRED 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.
• Ability 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.
• Ability to think and adapt to a rapidly changing environment and demands.
• Occasional work outside of normal business hours, including evenings, weekends, and holidays, may be required based on business needs.
• Working conditions and physical requirements:
  • Must be able to lift, carry, push and/or pull 40 pounds of equipment or supplies
  • May need to work with hazardous materials
  • Able to stand up for 4 hours at a time

EOE MFDV