Job Title

Requisition

Location

Additional Locations

Job 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.

Controlled Substances Waste Inventoried, Documented, and Secured:

• Accumulates, organizes, and maintains physical inventory of unusable controlled substance material that is received from production, customers, carriers, outside warehouses, Quality, and Research & Development (R&D).
• Manages destruction of controlled substances with internal stakeholders by performing verification; coordinate controlled substance destruction; correspond with local Drug Enforcement Administration (DEA) office to schedule destructions and forward completed DEA Form 41s.
• Responsible for data entry into inventory control system of all waste transactions.

DEA 222 Forms and Required Records Completed On Time:

• Gathers, compiles, and transmits data for quarterly and annual ARCOS reports to DEA.
• Issues and clears DEA 222 Forms when required to meet the needs of the business.
• Reviews DEA 222 Forms for compliance with the regulations (internal process review).
• Pulls copies of requested DEA 222 Forms for DEA and Customer Service

Daily Shop Order Reconciliation Ensures Accurate Inventory:

• Reviews controlled substance manufacturing/ packaging records to ensure accountability for all controlled substance materials during conversion from raw materials into finished product.

DEA Required Records and Reports Completed on Time and Within Guidelines:

• Maintains DEA records for updates and completeness including working with Legal to ensure up-to-date state licenses.
• Receives and retains all signed packing lists from customers for the receipt of controlled substances.
• Compiles and assembles all information in support of "Year-End Report for Substances Procured" to include complete and accurate accounting summaries and supporting documentation of all controlled substance activity/inventory within the plant for a given year.

Check Weight Receipt of Controlled Substances:

• Validates the accuracy of controlled substance deliveries by performing weight checks to verify the amount received.
• Complete all necessary receiving documentation for the controlled substances.

Education:

High School diploma or equivalent.

Experience:

At least five years' experience within the pharmaceutical industry, preferably in the area of 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.

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 work flow; have ability to track and measure progress; be able to identify opportunities for synergy and integration; simplify complex processes.

• 90% of the time will be spent in a traditional office setting, and 10% in a manufacturing or laboratory environment.
• Must wear safety glasses and other protective items as required.

Sitting 75% of the day; standing or walking 25%.