Specialist, Controlled Substance Compliance - First Shift

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

Participate in the execution of the Company's Controlled Substances Compliance program by performing any or all of the following specific activities or other projects and activities as needed and directed by the Sr. Manager, Controlled Substances Compliance-Hobart.

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 when applicable.
• Responsible for data entry into inventory control system of all waste transactions.
• Perform scale verifications on scales needed to verify culls or receiving of controlled substances.

DEA 222 Forms and DEA Required Records/Reports Completed on Time and Within Guidelines:

• Complete DEA Form 222's and associated transactions when needed for samples, customer complaints, CMO, etc.
• 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
• Completes DEA shipping verifications upon request from DEA

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 (handwriting must be legible for handwritten cGMP and DEA receiving records).

Suspicious Order Monitoring Questionnaires (SOMQ) and Google Alert Monitoring:

• Reviews SOMQ's for completeness and works with customers to ensure all questions are answered and findings have been provided when applicable
• Escalates findings to Director and Sr. Manager, Controlled Substances Compliance when necessary
• Monitors Media Alerts Mailbox for applicable google alerts, reviews articles, pulls respective charge back data if found and escalates to Webster Groves Compliance team for follow-up

Email Mailbox Monitoring:

• Monitors Media Alerts Mailbox for applicable google alerts, reviews articles, pulls respective charge back data if found and escalates to Webster Groves Compliance team for follow-up.
• Monitors CS Compliance Mailbox for SOMQs and Customer Service related escalations
• Reviews new application Controlled Substances Related Documents (SOMQ, DEA license, State license) to ensure compliance with applicable laws and advises Data Integrity on Operating Injunction set up codes

State Licensing and Sales Reporting:

• Maintains records for updates including working with Legal to ensure up-to-date state licenses.
• Receives state licenses and posts on the respective site state licensing boards.
• Compiles all required state sales reports and uploads to respective state web portals as required.

Internal Process Reviews (IPR):

• Generates an annual IPR schedule by month and reviews with Sr. Manager for approval to ensure all appropriate areas are audited on an annual basis.
• Completes the required monthly IPR and generates report for review and approval
• Follows up on any corrective actions required with a follow-up IPR on a 60 or 90 day basis

Cross Training and Team Flexibility:

• Candidate will be expected to perform any of the tasks listed above

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. Handwriting must be legible.

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%.

Salary Range - $59,535 - $95,256