DEA Compliance Coordinator

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Description

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.

Requirements

Qualifications and Skills

• Experience: 2-5 years of regulatory compliance experience in pharma, biotech, or manufacturing.
• Regulations: Deep working knowledge of DEA regulations and 21 CFR Part 1300.
• Software: Proficiency with ERP systems (like SAP or Oracle) and vault inventory tracking software.

Physical Requirements

• Constantly required to see to utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
• Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
• Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
• Frequently required to sit, and occasionally required to stand or walk to move around primarily in an office environment.
• Occasionally lift and/or move up to 10 pounds.

The salary range for this position is $60,000 to $90,000, with the final offer determined based on factors such as the candidate's experience, qualifications, skills, and education. In addition to a competitive base salary, this position is eligible to participate in Phlow's bonus and stock option programs. Phlow also offers a comprehensive benefits package that includes medical, life, and disability insurance; retirement savings plans; paid time off and company holidays; and education-related benefits. Many of these programs are fully funded or significantly subsidized by the company, reflecting our commitment to supporting the health, well-being, and professional development of our employees.