Job Title
Controlled substance Compliance (Quota) SpecialistRequisition
JR000014154 Controlled substance Compliance (Quota) Specialist (Open)Location
St. Louis, MO (Pharma) - USA032Additional Locations
St. Louis, MOJob Description
Responsible for continually monitoring processes and procedures primarily for inventory control of controlled substances active pharmaceutical ingredient (API) and finished dose, preparation of U.S. Drug Enforcement Administration (DEA) controlled substances quota requests and reporting of controlled substances transactions in accordance with state and federal controlled substances regulations and International Narcotics Control Board (INCB) reporting requirements. The candidate will also be expected to provide DEA regulatory guidance to internal stakeholders.
Essential Functions
Controlled Substances Quota
Controlled Substances Accountability
New Substances/Production Methods
DEA Reporting
Minimum Requirements
Education
Experience
At least five years of experience within the pharmaceutical industry, preferably in the areas of controlled substances quota management, manufacturing, quality assurance or regulatory compliance. Experience in interpreting and implementing the regulatory requirements associated with the use of controlled substance materials during all aspects of the pharmaceutical manufacturing and distribution process.
Other Skills/Competencies
Communication
The individual in this role will interact with many internal stakeholders across various functions as well as the DEA so must have the ability to communicate concisely and effectively verbally and in writing.
Attention to Detail
Must be thorough and precise in accomplishing a task with concern for all aspects involved; monitor and check work or information and plans for accuracy and consistency; provide information on a timely basis and in a usable form to others who need to take action.
Escalation Process Adherence
Must understand the scope of their decision-making authority; possess ability to sort through facts and personal knowledge to determine if an issue can be managed effectively or requires escalation to someone with additional knowledge without allowing much time to lapse prior to making the decision to elevate; demonstrate ability to clearly and concisely explain issues to senior leadership and ensure appropriate handoff to the next level has occurred.
Priority Setting and Time Management
Must appropriately manage time, organize resources efficiently, and prioritize tasks.
Process Management
Must be adept at identifying the processes necessary to accomplish tasks; understand how to organize people and activities while separating and combining tasks into efficient workflow; have ability to track and measure progress; be able to identify opportunities for synergy and integration; simplify complex processes.
Working Conditions
Disclaimer
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.