DEA Compliance Specialist
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DEA Compliance Specialist: Ascent seeks a DEA Compliance Specialist for its Central Islip, NY location. The ideal candidate will have 3+ years of experience in a similar position within the pharmaceutical manufacturing industry. Candidate must have a proven track record of success in dealing with state and federal agencies. The DEA Compliance Specialist, reporting to the VP – DEA Compliance, is knowledgeable on matters of the DEA as it pertains to pharmaceutical testing, manufacturing and distribution of controlled substances. This includes licenses, procurement, and movement of material, production, shipment and destruction. Incumbent must also have the ability to interface with governmental agencies and represent the company as needed
Responsibilities
- Coordinate DEA compliance matters at the site, including but not limited to licenses, procurement, movement of material, production, shipment and destruction
- Interface with governmental agencies and represent the company as needed
- Coordinate movement of controlled substances from manufacturing through analytical testing
- Conduct year-end and biennial inventory and report ARCOS quarterly reporting and cycle count inventory
- Liaise with Procurement and DEA regarding import/export of controlled substances and complete necessary paperwork and reports
- Maintain compliance of all DEA, State and Board of Pharmacy registrations
- Coordinate all controlled substance destruction with QC, Safety and Logistics departments
- Work with the Security department to maintain facility upgrades to security systems
- Responsible for completing, maintaining, and tracking DEA 222 forms
- Maintain organized DEA files on related activities and assist in quota applications to the DEA
- Coordinate and document DEA audits for site and issue audit reports to management upon completion
- Keep abreast of current DEA regulations in order to address organizational business needs
- Participate and represent department at project meetings as required
Qualifications
- Bachelor’s degree in a relevant field
- 3+ years of pharmaceutical controlled substance experience in the manufacturing industry
- ERP Systems experience required
Benefits
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
We offer a comprehensive compensation package which includes medical, dental, vision and life insurance as well as an employer-matched 401(k) plan. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Applicants must be legally authorized to work in the US. Verification of employment eligibility will be required as a condition of hire, together with passing background check and drug testing.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or protected veteran status. Nothing in this job positing or description should be construed as an offer of guarantee of employment.