Sr. Diversion Control Specialist

Job Summary

The Sr. Diversion Control Specialist is responsible for ensuring plantwide compliance to DEA, NYS, FDA, and cGMP requirements related to controlled substances with a focus on diversion and theft prevention at the Grand Island facility. The role supports the Controlled Substance Sr. Manager with efficient operations of the Controlled Substance Department and ensures a constant state of site readiness for internal and external audits, regulatory inspections and audits.

Salary Range: $73,164‑$103,528. Final pay determinations will depend on various factors, including experience level, education, knowledge, skills, and abilities.

• 401(k) plan with company contributions
• Paid vacation, holiday, and personal days
• Employee assistance program
• Medical benefits, including prescription drug coverage
• Dental and vision coverage
• Life insurance, disability benefits, and wellness program

• Assures compliance with state and federal laws as regulated by the state board of pharmacy, the Drug Enforcement Administration, and the Food and Drug Administration.
• Contributes to and reviews new and existing regional SOPs to ensure alignment with global procedures and operational efficiency.
• Assists other personnel (as needed) with subject‑matter expertise/guidance related to DEA reporting/internal audits, findings, and recommendations.
• Supports and facilitates the implementation of agreed‑upon management actions after internal audits (including Global FSE recommendations).
• Ensures DEA compliance with facility’s DEA registrations – e.g., required biennial inventories, ARCOS reporting, procurement quota submissions, YERS, etc.
• Maintains an up‑to‑date DEA readiness binder (in coordination with the CSC Team).
• Facilitates alarm tests to ensure adequate coverage of all controlled substances storage areas.
• Monitors vault (or cage) capacity to ensure adequate security exists to support increased controlled drug storage volume.
• Assists with mock audits/inspections for enhanced DEA inspection readiness.
• CS inventory management – review of CS raw material inventory, oversight of CS stored in the vault (for WIP and FP), ensures physical inventory matches electronic inventory, conducts year‑end inventory.
• Coordination of import and export of CS – applying for CS permits and declaration, ensuring appropriate teams are aware, working with Warehouse to schedule export, providing DEA required return information, filing CS documentation for all import/export.
• Completes and/or ensures all controlled substance records from departmental activities are complete, accurate, and readily retrievable.
• CS waste management – reconciliation of CS waste, completes necessary paperwork for DEA and appropriate state reporting for CS destruction.
• Supports CS analytical reference standard purchases for domestic and imported CS reference standards (where applicable).
• Maintains all controlled substance storage and production areas, ensuring security, accountability, and reporting requirements are adhered to, in conjunction with the CSC Team.
• Adheres to dotted line reporting and functional reporting needs to support controlled substance compliance.
• Supports Primary SNSR with relevant duties as needed.
• Responsible for compliance with controlled substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities.
• Provides oversight in the manufacture, distribution, and testing of controlled substance products.
• Ensures surveillance activities for controlled substance manufacturing, including incoming inventory control, waste collection and destruction, and release.
• Works with the Security Officer to ensure appropriate security controls are in place.
• Works with the Director of Materials Management to update and control the Surveillance and Access List.
• Reviews, inspects, and audits processes and documentation to verify accuracy and compliance at critical process points.
• Performs reconciliation of controlled substance raw material and critical calculations related to accountability.
• Supports on‑time controlled substance batch release.
• Reviews and assists in the investigation of deviations in controlled…