Lantheus is looking to improve the efficiency and compliance of its product shipment operations by hiring a Product Shipment Supervisor to oversee a team responsible for packaging, labeling, and documenting product shipments, as well as managing inventory control.
Requirements
- Minimum of 2 years of experience in a regulated manufacturing environment
- Must have a broad knowledge of cGMPs and applicable regulatory compliance requirements.
- Demonstrates a detailed understanding of ERP/MRP and inventory control systems and processes.
- Understands the importance of timely cycle counts and accurate inventory transactions in the realm of the operations and how they affect the Manufacturing/Supply Chain success.
Responsibilities
- Ensures that operations are performed per established SOP’s and the collection and maintenance of data are performed in accordance with cGMP’s, company standards and policies, and other regulatory requirements.
- Develops meaningful metrics used to manage operational performance. Looks to identify leading indicators that may result in process improvements or efficiency of operations.
- Ensures a safe working environment and a staff trained in safety consciousness, working with hazardous radioactive materials.
- Has strong understanding of ERP systems for managing inventory and ensuring supplies and raw materials are available for critical processes.
- Interacts with external regulatory inspectors from FDA, EMEA, DOT, NRC, etc., and internal compliance auditors during in-plant inspections. Ensure timely completion of any corrective and preventive actions (CAPA) made.
- Provides a strong Quality commitment by maintaining a thorough knowledge of current and emerging US and International guidelines (FDA, DOT, IATA, cGMP).
- Writing and reviewing of investigational reports, SOPs, and the timely resolution and tracking of Quality Events (deviations, investigations, CAPAs).
Other
- This position is site-based and requires a presence on-site three days per week.
- Oversees daily operations and schedules for the team handling product packaging, labeling, and shipment.
- Facilitates clear concise communication between team members, management, and external groups.
- Develops training materials and oversees team member training.
- Collaborates with manufacturing leadership team to progress cross-training and operational excellence initiatives.
