DEA Compliance Coordinator

At Phlow, we are creating the future of how medicines are made. As a pharmaceutical manufacturing company, we are focused on developing and manufacturing critical medicines using innovative approaches to improve the security, reliability, and resilience of the U.S. pharmaceutical supply chain. We are seeking a detail-oriented DEA Compliance Coordinator to oversee our controlled substance operations. You will ensure all facility activities strictly align with Drug Enforcement Administration (DEA) regulations and Title 21 Code of Federal Regulations (CFR).

This role is critical in maintaining our regulatory licenses, managing secure inventory, and preventing product diversion as it relates to API manufacturing.

Key Responsibilities

• Regulatory Reporting: Prepare and submit accurate monthly and annual ARCOS reports.
• Quota Management: Manage and file annual, procurement, and supplemental DEA quota applications.
• Order Forms: Execute, track, and log DEA-222 forms for Schedule I and II controlled substances.
• Inventory Control: Lead biennial physical inventory counts and investigate any inventory discrepancies, including at third party facility locations.
• Disposal & Destruction: Coordinate the secure reverse-distribution and destruction of controlled waste.
• Audit Readiness: Serve as the primary point of contact for federal DEA inspections and internal audits.
• Standard Operating Procedures: Write, update, and enforce compliance SOPs across the facility.