DEA Compliance & Controlled Substances Specialist

Argenta (New Zealand); Shawnee (KS); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

Argenta is seeking a Controlled Substance Specialist at our Shawnee, KS location to oversee and ensure compliance with CSA, DEA regulations, and state licensing requirements. The role supports audits, registrations, and reporting across the site, driving timely corrective actions and training to teams.

The candidate will bring a minimum of five years in regulated environments, familiarity with DEA inventories, and strong collaboration across functions to maintain inspection readiness and

Formación

• Bachelor's degree in science or equivalent work experience.
• 5+ years in pharmaceutical manufacturing or regulated environments.
• Working knowledge of FDA and DEA regulations.
• Experience with DEA Schedule II-V inventory controls and recordkeeping.
• Ability to translate regulatory requirements into practical site-level compliance actions.
• Experience supporting DEA audits, inspections, or regulatory inquiries.
• Collaborative mindset with ability to work across functions.

Responsabilidades

• Controlled Substance Compliance - ensure site operations comply with all applicable regulations (DEA, and other relevant authorities) and internal quality standards.
• Audit & Inspection Management Support - lead and coordinate internal audits and support external regulatory inspections and client audits.
• Support and maintain controlled substance compliance programs to meet all applicable DEA and state requirements, including manage DEA registration renewals and modifications.
• Serve as the primary site contact for DEA field offices and state board of pharmacy, including the support of DEA Form 41, DEA Form 222, ARCOS, and other reporting requirements.
• Conduct controlled substance audits and risk assessments to identify compliance gaps, including reconciliation and accountability of inventory.
• Provide training to employees on controlled substance compliance.
• Maintain detailed records and documentation for controlled substance inspection readiness documentation.
• Report non-compliance issues to management and propose corrective actions.
• Coach colleagues to facilitate knowledge transfer regarding NCR investigations.
• Support and participate in controlled substance investigations, deviations, root cause analyses, and CAPA activities.

Conocimientos

Regulatory compliance

DEA regulations

FDA regulations

Inventory controls

Audits & inspections

Cross-functional collaboration

Attention to detail

Educación

Bachelor's Degree in science

Descripción del empleo

Argenta is seeking a Controlled Substance Specialist at our Shawnee, KS location to oversee and ensure compliance with CSA, DEA regulations, and state licensing requirements. The role supports audits, registrations, and reporting across the site, driving timely corrective actions and training to teams.

The candidate will bring a minimum of five years in regulated environments, familiarity with DEA inventories, and strong collaboration across functions to maintain inspection readiness and