Job ID: 224663424
3 - 5 years
The Manager, Controlled Substance is responsible to assure and maintain comprehensive standards of Quality and Compliance to DEA and NYS guidelines and regulations, as well as, FDA and cGMP requirements related to the manufacture and release of controlled substances at the Grand Island facility.
This position is critical as it relates to controlled substance activities; penalties for non-compliance in this area are severe.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
- Assures compliance with state and federal drug laws as regulated by the state board of pharmacy, the drug enforcement administration, and the food and drug administration.
- Maintains records for controlled substances. Ensures that all inventories are performed properly, documented and reported accurately.
- Maintains current registration; studying existing and new legislation; anticipating legislation; advising management on needed actions.
Coordinates the surveillance activities for controlled substance manufacturing, including incoming, inventory control, waste collection and destruction, and release.
Serves as DEA liaison for inspection and contacting requirements.
During inspections, insures daily reports summarizing all topics discussed and records provided.
- Interacts with training personnel to assure compliance to DEA and FDA training requirements
- Coordinates transition of new controlled substance products into the operation
- Assists with development and maintenance of department budget.
- Represents department at meetings related to all controlled substance activities, including security.
- Performs other duties and projects as assigned by management
Are responsible for
- Promotes continual improvement taking accountability for the effectiveness of the Environmental/Energy Management System.
- Full accountability for ensuring Health, Safety and Environmental requirements are adhered to
- Bachelor’s degree in Pharmacy required
- Licensed Pharmacist in NYS
- Experience in tracking/accountability of controlled substances
- Knowledge of DEA/NYS regulations for controlled substances
- Demonstrated ability to interface with appropriate federal agencies