The objective of this position is to supervise the receiving and product shipment warehouse operations and staff associated with the receiving and shipment of same-day release radioactive imaging agents and to ensure that they are performed in a timely manner compliant with all cGMP, OSHA, NRC, DOT, IATA and other regulatory requirements, based on business needs. Ensures the integrity and quality of data generated and that employees are trained and comply with operating procedures to meet all cGMP and safety requirements. Responsible for all aspects of Finishing Operations processes used in the receipt and shipment for the same.
Key Responsibilities/Essential Functions
- Supervise day to day operations, scheduling of Finishing Operations receiving warehouse and product shipment personnel, monitoring of workload for weekday operations (plus weekend operations, as applicable) through the application of cGMP?s, safety, personnel, and performance management policies.
- Ensures that operations are performed per established SOP?s and the collection and maintenance of data are performed in accordance with cGMP?s, DOT, IATA, and company standards and policies, and other regulatory requirements.
- Strong understanding of ERP systems (BPCS LX) for managing inventory.
- Participates in continuous review/upgrade of warehouse and product shipment functions and ensures methods are current and validated to achieve a high performing, efficient, and flexible work environment.
- Ensures supplies and raw materials are available for critical processes.
- Interact 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.
- Provide a strong Quality commitment by maintaining a thorough knowledge of current and emerging US and International guidelines (FDA, DOT, IATA, cGMP).
- Develops and oversees new team members training as well as existing team members cross-training development plans.
- Ensures a safe working environment and a staff trained in safety consciousness, working with hazardous radioactive materials.
- Recommends merit increases for team members. Provides appropriate recognition for team members for exceeding expectations. Develops remedial action for team members whose performance does not meet standards.
- Writing and reviewing of investigational reports, SOPs, validation protocols, and the timely resolution and tracking of Quality Events (deviations, investigations, CAPAs).
- Tracks departmental spend and manages internal budgets. Adheres to company policies and guidelines; exercises good judgment when incurring expenses.
- Develops meaningful metrics used to manage operational performance. Looks to identify leading indicators that may result in process improvements or efficiency of operations.
- Facilitates clear concise communication between team members, management, and external groups. Supports group involvement on committees. Takes a lead role on committees.
- Leads and develops staff to achieve professional growth and attain established goals. Establishes personal objectives which align with the team and organizational goals.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
- Actively demonstrates the Lantheus values of Accountability, Quality, Efficiency, Customer Service, Collaboration, and Safety.
- Bachelor?s degree in Scientific Discipline or Business Management with minimum of 5years relevant experience in the pharmaceutical industry, warehousing, inventory management or equivalent.
- A combination of education, training, and experience may be considered in lieu of above stated requirements.
- A minimum of 2years? leadership experience. Examples of relevant roles are: Supervisor, Group/Team Lead, Project Lead, and Trainer.
- Must have a broad knowledge of cGMPs and warehouse DOT, IATA regulatory compliance requirements.
- Must be detail oriented with the ability to multitask, strong team player, and be able to collaborate with all levels of management.
- Ability to lead and direct work of others as well as ability to respond to ever changing priorities.
- Unscheduled work occasionally required on evenings, weekends, holidays, and in adverse weather conditions.
- Experience writing protocols, procedures, reports, and investigations.
- DOT and IATA certification is a plus.
- Knowledge of data analysis with appropriate statistical evaluation and trending a plus.
- Knowledge of Six-Sigma, 5S, and otherLean processes a plus.