Description
Cambrex
DEA Compliance, Manager
US-IA-Charles City
Job ID: 2025-4539
Type: Regular Full-Time
Category: Regulatory Affairs
Cambrex - Charles City
Overview
Position is responsible for ensuring that Cambrex Charles City, Inc. (CCC) is compliant with Drug Enforcement Administration (DEA) regulations and requirements. This individual monitors day-to-day operations related to controlled substances (CS) and manages the overall site CS program. This individual will interact with regulators and customers on CS related matters, and represent the company during third party audits and inspections.
Responsibilities
- Responsible for monitoring and maintaining compliance with DEA regulations pertaining to shipping, manufacturing, analytical and research activities associated with controlled substances and listed chemicals.
- Maintain all related registrations with DEA and other agencies as needed.
- Maintain State licensure program. Complete associated reporting requirements.
- Complete and file ARCOS quarterly and year end reports.
- Maintain CS and listed chemical files including those pertaining to shipping, receiving, 222 forms, ARCOS reports and correspondence with the DEA or appropriate State agencies.
- Interface with DEA as needed, including written, oral and face to face interactions.
- Maintain records and correspondence relating to the destruction of CS.
- Maintain complete and accurate records pertaining to CS related operations and lab handling.
- Complete, reconcile and report all CS and listed chemical inventories.
- Assist all departments with CS related issues.
- Prepare and conduct employee training on DEA requirements and related site SOP's as needed.
- Author and maintain site SOP's and policies relating to CS operations and handling.
- Work with Sales/Marketing and customers to obtain appropriate volume requests for CS quota.
- Liaise with customers and represent the site during audits and inspections related to CS handling.
- Participate on project teams for new project onboarding; liaise with DEA as needed to facilitate CS-related issues such as registration updates, quota needs, controlled status determinations, etc.
- Oversee shipment of CS, including import, export and management of suspicious order monitoring program.
- Oversee security programs related to CS handling and mfg.
All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.
Qualifications
- 4 year degree, preferably in Chemistry, Biochemistry, Biology or Engineering.
- 5 or more years of experience in administering controlled substances or products with strict regulatory guidelines. Strong working knowledge of DEA regulatory requirements highly beneficial.
PI279244706
