Controlled Substance Compliance Associate

Since 1990, we’ve grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations across Europe, North America, South America, Africa, and Asia-Pacific, working together to support over 200,000 customers worldwide. From compounding and natural products to software, equipment, and genomics, we deliver smart, ready-to-use solutions that make healthcare better. We’re passionate, science-driven, and always looking for new ways to improve lives.

About the role

The Controlled Substance Compliance Associate will support the DEA compliance profile by acting as the primary entity responsible for all logistics associated with the daily activities for all Controlled Materials at Fagron Sterile Services. This dedicated position executes the logistics associated with raw material and finished product movements and required documentation, coordinates sample inspection and transfer, VI and labeling, inventory reconciliation, and correct disposal. Additionally, the role ensures that all controlled-substance-related activities occur in a consistent manner and serves as liaison to other functional areas within FSS in support of an overall culture of awareness and DEA compliance.

Responsibilities

• Correct and consistent execution and documentation of all controlled-substance material transactions: vault check-in/out, inventory reconciliation, sampling and disposal, finished-product sales record (examples include Perpetual Inventory Records, Reverse Distributor Manifest Forms (DEA Form 222 as applicable), Transfer Forms, Yearly Reconciliation Summary Forms).
• Support Aseptic Compounding and Filling teams throughout the manufacturing process: API check-out and transfer (electronic inventory) to PROD IN, return check-in of API and finished product, recording of consumption, finished-product unit and reject-count verification, line-flush disposal, etc.
• Track and communicate batch-release status (delays due to deviations/unplanned events), raw-material availability, and inventory levels.
• Communicate with Operations, Post-Production, and FSS Labs as needed to request support: VI and labeling, testing and method validations, etc.
• Execute all inventory reconciliation and expired-inventory disposal activities.
• Maintain current electronic inventory in alignment with official paper record.
• Continuous monitoring of material accountability records for errors, completion of review, and verification signatures.
• Assist CS Compliance Management in preparing and submitting monthly/quarterly reports (i.e., ARCOS).
• Support operations by acting as subject-matter expert in ensuring DEA and site-procedure compliance for all daily activities.
• Assist with development and growth of a Security culture among all colleagues and contractors to help ensure controlled-substance compliance.

Requirements

• High School Diploma or equivalent required.
• Excellent time-management skills and ability to self-direct in managing concurrent requirements.
• Ability to communicate clearly and professionally with colleagues, customers, and suppliers in person, on the phone, and in writing.
• Excellent attention to detail and commitment to maintaining consistency and compliance with established procedures.
• Proactive, problem-solving mindset with ability to identify and correct errors, offer improvement recommendations, and embrace ownership of complex processes.
• Must be able to meet all requirements for handling of controlled substances.
• Working knowledge of Good Documentation Practice (GDP) principles as they relate to a pharmaceutical manufacturing environment.
• Previous work experience in a regulated manufacturing industry is a plus.
• Familiarity with and/or willingness to learn ERP system tracking and management.

Benefits

• Competitive salaries
• 401(k) plan with company matching contribution
• Medical, vision, and dental coverage
• Health Savings Account (HSA)
• Holiday and paid time off

At Fagron, you’ll find plenty of chances to grow both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.