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Pharmatech Associates is seeking an experienced DEA Compliance Consultant / Subject Matter Expert (SME) for a consulting engagement. The primary objective of this assignment is to evaluate a client's proposed DEA-regulated operations and determine the feasibility of moving forward with manufacturing. The consultant will conduct an operational and compliance assessment, identify regulatory and business risks, evaluate the client's current state, and recommend areas where Pharmatech Associates can provide consulting and implementation support.

Primary Responsibilities Phase 1 – Proposal & Operational Assessment

• Review the client's proposed business model, facility plans, operational workflows, and controlled substance activities.
• Evaluate the client's readiness to support DEA-regulated manufacturing, distribution, storage, laboratory, or supply chain operations.
• Assess existing processes, documentation, and compliance programs against DEA regulations and industry best practices.
• Identify compliance gaps, operational risks, and areas requiring further development.
• Develop a comprehensive assessment report outlining findings, risks, recommendations, and opportunities for Pharmatech Associates to support the client.
• Present findings and recommendations to Pharmatech Associates and the client to assist with project go/no-go decisions

Phase 2 – Consulting & Implementation Support Operational Compliance & Manufacturing Support

• Evaluate manufacturing, warehouse, laboratory, and distribution operations to ensure controlled substance processes meet DEA requirements and business objectives.
• Advise on compliant workflows for receiving, weighing, dispensing, manufacturing, packaging, storage, shipping, returns, and destruction of controlled substances.
• Collaborate with Operations, Manufacturing, Supply Chain, Quality, Engineering, Security, and Regulatory Affairs to strengthen operational compliance.
• Recommend practical process improvements that enhance both operational efficiency and regulatory compliance.

Inventory Management & Controlled Substance Accountability

• Assess inventory control systems for raw materials, APIs, work-in-process (WIP), finished goods, samples, and returned controlled substances.
• Evaluate reconciliation processes and material accountability throughout manufacturing and distribution.
• Support inventory programs, discrepancy investigations, and chain-of-custody controls.

Facility & Security Assessments

• Evaluate controlled substance storage and handling areas, including vaults, cages, manufacturing suites, laboratories, warehouses, and shipping/receiving operations.
• Assess physical security, access controls, surveillance, alarm systems, and diversion prevention measures.
• Recommend improvements aligned with DEA expectations and operational requirements.

Compliance Program Development

• Develop or enhance SOPs, work instructions, and operational controls supporting DEA-regulated activities.
• Assist with diversion prevention programs, suspicious order monitoring (SOM), customer due diligence, and internal compliance monitoring.
• Support development of sustainable compliance programs tailored to the client's business model.

Audit & Inspection Readiness

• Conduct operational assessments, mock DEA inspections, and internal audits.
• Identify compliance gaps and assist in developing corrective and preventive action (CAPA) plans.
• Support investigations involving inventory discrepancies, security events, or operational compliance issues.

Regulatory Guidance

• Provide expertise on the Controlled Substances Act (CSA), DEA regulations (21 CFR Parts 1300–1321), and applicable state regulations.
• Assist with ARCOS reporting, DEA Forms 222/CSOS, DEA Form 106, quota management, and other regulatory requirements, as applicable.
• Interpret regulatory expectations and translate them into practical operational solutions.

Training & Knowledge Transfer

• Develop and deliver training for manufacturing, warehouse, quality, laboratory, and supply chain personnel.
• Mentor client teams on inventory accountability, documentation, diversion prevention, and inspection readiness.
• Serve as a trusted DEA compliance advisor throughout the engagement.

Desired Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Engineering, Life Sciences, Supply Chain, Business, or a related field.
• Extensive experience supporting DEA-regulated pharmaceutical manufacturing, distribution, logistics, or healthcare operations.
• Strong knowledge of controlled substance operations, inventory management, warehouse operations, and supply chain controls.
• Working knowledge of the Controlled Substances Act (CSA), DEA regulations, and controlled substance security requirements.
• Experience conducting operational assessments, gap analyses, audits, inspections, or compliance reviews.
• Proven ability to identify compliance risks and develop practical, business-focused solutions.
• Experience developing SOPs, compliance programs, and operational improvements.
• Excellent communication, facilitation, and stakeholder engagement skills.

Preferred Qualifications

• Experience supporting pharmaceutical manufacturers, CDMOs, API manufacturers, wholesale distributors, or DEA-regulated logistics providers.
• Knowledge of cGMP, FDA quality systems, and pharmaceutical manufacturing operations.
• Experience with ERP, warehouse management, inventory management, and manufacturing execution systems.

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

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