Sr. Diversion Control Specialist

Fresenius Kabi USA•Wilson, NC

About The Position

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. Supports the Controlled Substance Sr. Manager with efficient operations of the Controlled Substance Department. Ensures a constant state of site readiness for controlled substance internal and external audits, and all regulatory inspections and audits. Salary Range: $73,164-$103,528 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

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 – (ex: 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, ensure appropriate teams are aware of CS imports and exports, works with Warehouse to schedule export of CS, provide DEA required return information for imports and exports of CS, filing of CS documentation for all imports and exports.
Completes and/or ensures all controlled substance records from all 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, ensure security, accountability, and reporting requirements are adhered to (in conjunction with 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 Security Officer to ensure appropriate security controls are in place.
Works with Director, Materials Management in updating and controlling 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.
Performs critical calculations as they relate to controlled substance accountability.
Supports on-time controlled substance batch release.
Reviews and assists in the investigations of deviations of controlled substance accountability / reconciliation issues.
Implements and executes annual diversion control self-assessment program to assess the facility’s state of readiness for regulatory inspections.
Implements audit program for controlled substances and routinely performs audit of controlled substance records.
Implements process improvements related to controlled substance accountability and reconciliation.
Provides support during internal and external audits, and all regulatory inspections and audits.
Assists the Sr. Manager, Controlled Substance, with DEA required reporting of controlled substances and the applications for imported or exported controlled substances.
Serves as a resource to others in the interpretation of 21 CFR Part 1300 – end.
Authors departmental SOPs.
Ensures plant-wide compliance to controlled substance SOPs.
Exhibits leadership and guidance in mentoring those who handle and work with controlled substances.
Coaching and reviewing the work of lower-level employees along with training new employees on regulatory compliance issues and policies.
Coordinates transition of new controlled substance products into the operation.
Works with procurement on the ordering of controlled substances and reference standards.
Coordinates the shipping and receiving of controlled substance finished products and samples which includes imported and exported controlled substances.
Represents department at meetings related to all controlled substance activities.
Acts as the backup to the Site Narcotic Substance Responsible (SNSR).
Ensures efficient operations of the Controlled Substance Department when the Sr. Manager is unavailable.
Performs other duties and projects as assigned by management.
All employees are responsible for ensuring the compliance to company documents, programs and activities related to Occupational Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities.