DEA Controlled Substance Compliance Specialist

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
DEA Controlled Substance Compliance Specialist is responsible for the oversight of the Controlled Substance Program at KDD. This role ensures regulatory compliance with the Drug Enforcement Administration (DEA) and state laws governing controlled substances, including storage, handling, distribution, and reporting. In this role the specialist provides leadership in regulatory audits and inspections, maintains the integrity of the controlled substances inventory and support manufacturing, laboratory, and warehouse departments in resolving base business needs associated to Controlled Substance Management.
This role is critical in maintaining adherence to DEA regulations, processing Standard Operating Procedures (SOPs), and regulatory compliance for controlled substances. The individual must demonstrate strong leadership and organizational skills, collaborating with Operations, Quality Assurance, Security, and other departments to ensure compliance and prevent risks related to controlled substances.
Role Responsibilities

• Ensure compliance with DEA regulations (21 CFR Part 1300) and relevant state laws regarding the handling, storage, distribution, and destruction of controlled substances.
• Monitor changes in regulations and update internal processes and policies as needed to maintain compliance.
• Serve as the primary point of contact during client and regulatory audits and inspections, ensuring the site is audit ready.
• Ensure facility Controlled Substance registrations, permits, and state licenses are current and compliant with all regulatory requirements and submitted in a timely manner.
• Ensures DEA 222 Forms & required records are completed accurately and on time.
• Ensures DEA ARCOS reports are completed on time and within guidelines.
• Ensures completion of quarterly and annual reports for submission to DEA.
• Oversees the DEA permit process for imports and manufacturing of controlled substances.
• Manages discrepancy investigations, and the filing of DEA106 Reports as needed.
• Primary POC for DEA and state-controlled substance inspections.
• Ensures applications for renewal of DEA registration is submitted in a timely manner.
• Manages destruction of controlled substances with internal clients by performing verification and coordination of controlled substance destruction; corresponds with local DEA office to schedule destructions and forward completed DEA Form 41s.
• Provide training and education to staff on proper handling, documentation, and storage of controlled substances.

Qualifications

• Education: Bachelor’s degree in science, pharmacy, chemistry, biology, or a related field is preferred.
• Experience:
• 5 years of experience in regulatory compliance and handling of controlled substances, including experience in a pharmaceutical or distribution facility.
• Knowledge of DEA regulations (21 CFR Part 1300) and familiarity with state pharmacy regulations.
• Experience with Electronic Quality Management Systems, such as Trackwise, compliance audits, and regulatory reporting.

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California residents should review our Notice for California Employees and Applicants before applying.

Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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