Controlled Substance Specialist

Argenta•Shawnee, KS

About The Position

The Controlled Substance Specialist is responsible for the oversight, administration, and compliance of site activities involving controlled substances regulated under the Controlled Substances Act (CSA), Drug Enforcement Administration (DEA) regulations, and applicable state licensing requirements. The position supports compliance programs, audit and inspection readiness, controlled-substance investigations, and employee training at Argenta’s Shawnee, Kansas location.

Requirements

Bachelor’s degree in a science field such as Biology, Microbiology, Chemistry, or Pharmacy, or equivalent related work experience.
At least five years of experience in pharmaceutical manufacturing, analytical laboratory operations, controlled-substance compliance, regulatory affairs, or a related regulated environment.
Working knowledge of FDA and DEA regulations (21 CFR 1300 to end).
Experience with DEA Schedule II–V inventory controls and recordkeeping.
Ability to interpret regulatory requirements and translate them into practical site-level controlled-substance compliance actions.
Experience supporting DEA audits, inspections, or regulatory inquiries.
Familiarity with state controlled-substance licensing and reporting requirements.
Collaborative mindset and ability to work across functions with regulatory stakeholders and external clients.
Proactive, entrepreneurial approach to identifying and resolving compliance risks.

Responsibilities

Ensure site operations comply with applicable DEA and other relevant regulations and internal quality standards.
Ensure timely and accurate delivery of compliance requests supporting client findings.
Lead and coordinate internal audits and support external regulatory inspections and client audits.
Support and maintain controlled-substance compliance programs that meet DEA and state requirements, including managing DEA registration renewals and modifications.
Serve as the primary site contact for DEA field offices and the state board of pharmacy.
Support DEA Form 41, DEA Form 222, ARCOS, and other applicable controlled-substance reporting requirements.
Conduct controlled-substance audits and risk assessments, including inventory reconciliation and accountability, to identify compliance gaps.
Support employee training on controlled-substance compliance.
Maintain detailed records and documentation for controlled-substance inspection readiness.
Report controlled-substance non-compliance issues to management and recommend corrective actions.
Coach colleagues to facilitate knowledge transfer regarding quality nonconformance (NCR) investigations.
Support and participate in controlled-substance investigations, deviations, root cause analyses, and CAPA activities, ensuring timely completion and regulatory compliance.