Controlled Substance Specialist

Argenta; Shawnee (KS); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Regulatory compliance

DEA regulations

FDA regulations

Inventory controls

Audits & inspections

Cross-functional collaboration

Attention to detail

Ausbildung

Bachelor's Degree in science

Jobbeschreibung

At Argenta, we're more than a company - we're a global team, dedicated to healthier animals. We believe that when their lives are made better, we're all the better for it.

Founded in 2006, we support companies big and small to develop and manufacture health products for pets and livestock. Our trusted, innovative solutions and services cover every stage of the process, from molecule to market.

We're in a unique position. We are the world's only combined contract research and contract development and manufacturing organization (CRO/CDMO) dedicated to animal health.

Our uniqueness means:

We are ambitious, growing and building a 'one team' culture, guided by our values.

• • We are team players;
  • We are doers;
  • We are customer-centric;
  • We are innovators

We value diversity, as a global company, we get the richness of working with different people in different places whether it be location, stages of their career, their development, their role. We believe that when everyone works together and puts their best "paw" forward we will make the lives of the animals we care for, better.

With bases in New Zealand, the US, the UK and Europe, our 900+ colleagues are driven by our partnership approach and purpose: Healthy Animals. Let's Make It Happen, Together.

TEAM PLAYERS who want to DO great work and find INNOVATIVE ways to make animals lives better through our CUSTOMER CENTRIC efforts should apply.

Argenta is currently looking to fill the role of Controlled Substance Specialist at our Shawnee, KS location. This role is responsible for the oversight, administration, and compliance of all activities involving controlled substances regulated under the Controlled Substances Act (CSA), Drug Enforcement Administration (DEA) regulations, and applicable state licensing requirements.

Key Responsibilities:

• Controlled Substance Compliance - ensure site operations comply with all applicable regulations (DEA, and other relevant authorities) and internal quality standards.
• Ensure timely and accurate delivery of compliance requests supporting client findings
• 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 controlled substance reporting requirements, as applicable
• Conduct controlled substance audits and risk assessments to identify compliance gaps, including reconciliation and accountability of inventory
• Provide support of training to employees on controlled substance compliance
• Maintain detailed records and documentation for controlled substance inspection readiness documentation
• Report non-compliance controlled substance issues to management and recommended corrective actions
• Coach colleagues to facilitate a focused knowledge transfer regarding the conduct of quality NCR investigations
• Support and participate in controlled substance investigations, deviations, root cause analyses, and CAPA activities, including ensuring timely completion and regulatory compliance

About You:

• Bachelor's Degree in science field, e.g., Biology, Microbiology, Chemistry, Pharmacy, etc. or equivalent related work experience required
• Minimum five+ years of experience in pharmaceutical manufacturing, analytical laboratory operations, controlled substance compliance, regulatory affairs, or related regulated environments
• Working knowledge of FDA and DEA regulations (21CFR1300 to end)
• Experience with DEA Schedule II-V inventory controls and recordkeeping
• Ability to interpret regulatory requirements and provide support by translate into practical site-level compliance actions for controlled substances
• Experience supporting DEA audits, inspections, or regulatory inquiries
• Familiarity with state controlled substance licensing and reporting requirements
• Collaborative mindset with the ability to work across functions, regulatory and external clients
• Entrepreneurial and proactive approach to identifying and resolving compliance risks

Argenta has strongly embedded company values which is key to who we are and how we deliver. We offer an opportunity to work for a successful and rapidly expanding global business where your input will be valued.At Argenta we are a hard-working group who really enjoy the people we work with each day. That is why we support our people through a strong culture, great benefits, and growth opportunities.

Argenta is an equal-opportunity employer