Controlled Substance Specialist 3rd Shift

About the role

This full-time Controlled Substance Specialist role is part of a mission-driven organization dedicated to expanding access to quality, affordable medication and data insights. The position supports a culture of innovation, collaboration, and continuous improvement while ensuring strict compliance with DEA regulations for handling Controlled Substances and List 1 Chemicals. The role operates on a consistent third-shift schedule (Monday–Friday, 10:00 PM–6:30 AM) at the Sugar Land, Texas site and may be subject to random drug testing in accordance with applicable laws.

Responsibilities

• Establish, maintain, and enforce procedures to prevent, detect, and investigate diversion of Controlled Substances and List 1 Chemicals
• Maintain complete records of every movement of Controlled Substances and List 1 Chemicals from receipt to delivery
• Monitor daily use to ensure continuous compliance with DEA regulations, company policies, and safety requirements
• Update department SOPs, investigate variances, and execute change controls to support compliance objectives
• Build cross-functional relationships with Quality, Manufacturing Operations, Supply Chain, and Pharmacy Services
• Complete in-process checks and verifications of Controlled Substances and List 1 Chemicals per SOPs
• Review documentation such as batch records to ensure compliance with policies, procedures, and Good Documentation Practices
• Prepare, execute, and maintain DEA Order Forms (222) for Schedule II transfers
• Initiate Notices of Events (NOEs), investigate deviations, and implement corrective actions
• Perform and record regular inventories to maintain accurate stock records
• Establish compliant procedures and work instructions aligned with regulatory, site, and corporate requirements
• Develop and deliver training programs to ensure staff handle Controlled Substances in a compliant manner
• Partner with teams to review operational performance and drive improvements via corrective/preventive actions and change controls
• Frequently physically transfer bulk materials and cased finished goods to and from controlled substance storage locations

Requirements

• Associate degree required; Bachelor’s degree preferred
• 1–2 years of relevant experience in project management, operations, regulatory compliance, and/or pharmaceutical environments
• 1–2 years of experience working with Controlled Substances and knowledge of DEA regulations
• Working knowledge of DEA regulatory requirements and applicable SOPs
• Working knowledge of safety standards and their application to improve safety culture and metrics

Skills

• Ability to communicate compliance requirements
• Ability to influence and persuade peers on cross-functional teams and resolve conflicts
• Strong prioritization and planning skills; ability to manage tasks based on criticality
• High attention to detail
• Effective time-management and goal-setting abilities
• Computer skills: Microsoft Office Suite; ERP software, INFOR a plus

Benefits

• Comprehensive health and wellness benefits including medical, dental, and vision
• 401(k) retirement program with company match
• 17 paid days off plus 8 paid holidays per year
• Opportunities for career advancement within a high-growth, national company