Material Handling Specialist
The ideal candidate will support the daily operations in a Weigh and Dispense area by handling materials, ensuring compliance with GMP standards, and maintaining equipment to ensure smooth operational flow.
Main Responsibilities:
* Operate and monitor weigh and dispense activities and support equipment, utilizing MES/DCS and PLC-based systems to ensure optimum equipment uptime and meet target outputs. Equipment includes, but is not limited to, downflow booths and scales.
* Perform cleaning, housekeeping, and materials management within the Weigh and Dispense area to maintain cleanliness and ensure material availability for production.
* Pick materials from stored locations in a GMP-compliant area and transport them to the production area according to SOPs and GMP standards.
* Move materials from production areas to the warehouse or other locations within the facility, adhering to SOPs and GMP guidelines.
* Follow instructions regarding the handling of materials from delivery vehicles to the facility, as well as dispatching materials from the facility.
* Ensure safe lifting and movement of materials in accordance with safety protocols.
* Pack out materials and consume to order to streamline processes for IPT (future state).
* Check the calibration of equipment regularly, ensuring it is up to date, and use the EBR to dispense materials in the Weigh & Dispense area.
* Manage equipment flow, including tracking soiled and clean hold times, ensuring proper labeling and inventory management of clean and sterile equipment using an automated MES system.
* Maintain process equipment, performing preventative maintenance, troubleshooting, and repairs where qualified.
* Participate in writing, revising, and rolling out accurate operational procedures, training materials for Weigh and Dispense processes, and material management in line with company standards.
* Support continuous improvement by contributing to investigations, creating investigation reports, executing and developing change control/QNs, and participating in relevant projects.
* Adhere to company policies, procedures, and regulatory requirements, executing current Good Manufacturing Practices (cGMP) in all activities.
* Collaborate with team members to foster a safe and compliant work culture.
Key Qualifications:
* Ability to lift up to 50 pounds.
* Basic computer skills.
* Prior FDA experience is highly preferred.