Controlled Substance Specialist

Position Summary

Turbare Manufacturing is seeking an experienced Controlled Substance Specialist to oversee the handling, tracking, and accountability of controlled substances within our FDA-registered 503B sterile compounding outsourcing facility. This role requires a seasoned professional with significant experience managing controlled substances in a pharmacy, pharmaceutical manufacturing, healthcare, distribution, or other highly regulated environment.

The Controlled Substance Specialist is responsible for maintaining inventory accuracy, ensuring regulatory compliance, supporting traceability requirements, performing inventory reconciliations, and safeguarding controlled substance inventory throughout the product lifecycle.

Essential Duties and Responsibilities

• Manage the receipt, storage, issuance, transfer, and accountability of controlled substances in accordance with federal, state, and company requirements.
• Maintain accurate inventory control of all controlled substance materials and finished products.
• Check controlled substance products and materials in and out of inventory locations while ensuring complete documentation of all transactions.
• Maintain chain of custody and product traceability through accurate lot number, expiration date, and inventory records.
• Perform routine and periodic controlled substance inventory reconciliations and investigate discrepancies.
• Monitor inventory levels and support procurement and replenishment activities as needed.
• Ensure compliance with DEA, FDA, state board of pharmacy, and company regulatory requirements.
• Maintain records and documentation necessary to support inspections, audits, and regulatory reporting.
• Assist with controlled substance audits, inspections, and inventory reviews.
• Collaborate with Quality Assurance, Production, Pharmacy Operations, and Warehouse personnel to ensure proper handling and control of regulated materials.
• Support the development and maintenance of procedures related to controlled substance management and accountability.
• Identify, document, and escalate inventory variances, compliance concerns, or potential diversion risks.
• Ensure secure storage and handling practices are consistently followed.
• Maintain compliance with current Good Manufacturing Practices (cGMP) and company quality systems.

Key Competencies

• Controlled Substance Management
• Regulatory Compliance
• Inventory Control
• Product Traceability
• DEA Compliance
• Reconciliation and Audit Support
• Attention to Detail
• Documentation Accuracy
• Problem Solving
• Risk Identification and Mitigation

Required

• Active Pharmacy Technician License in good standing.
• Minimum of 3–5 years of experience working with controlled substances in a pharmacy, pharmaceutical manufacturing, healthcare, distribution, or similarly regulated environment.
• Demonstrated knowledge of controlled substance inventory management, documentation, and accountability requirements.
• Experience performing inventory reconciliations and discrepancy investigations.
• Strong understanding of DEA regulations and controlled substance recordkeeping requirements.
• Exceptional attention to detail and organizational skills.
• Ability to maintain accurate records and work within highly regulated environments.
• Proficiency with inventory management systems and Microsoft Office applications.

Preferred

• Experience in a 503B outsourcing facility, sterile compounding pharmacy, pharmaceutical manufacturing facility, or hospital pharmacy.
• Knowledge of FDA regulations, cGMP requirements, and pharmaceutical supply chain controls.
• Experience supporting DEA audits, inspections, or controlled substance compliance programs.
• Advanced inventory management and reconciliation experience.

Physical Requirements

• Ability to lift and move materials up to 50 pounds.
• Ability to stand, walk, bend, and perform repetitive tasks throughout the workday.
• Ability to work in warehouse, pharmacy, and controlled manufacturing environments.