DEA Associate


Job ID 18-00216

Industry Pharma

Job Type Permanent

Location Dayton, NJ

Description

JOB SUMMARY
The qualified individual will be responsible for the daily movement of controlled substances related product and inventory verification of various departments as it applies to two manufacturing sites. The qualified individual will aid DEA related reporting to both state and federal regulatory agencies on a monthly and quarterly basis. The qualified candidate will perform verification and organization of submitted material for product transfers and material destruction. Understands and responsibly performs duties with attention to quality and detail.
 

REPORTING RELATIONSHIPS
Reports to DEA Manager, has no direct reports.
 

DUTIES & ESSENTIAL JOB FUNCTINS PERCENT OF TIME FREQUENCY ESSENTIAL DUTIES
15 Daily Verifies inventory logbooks and product movement along with department personnel
15 Daily Maintain, verify and organize ongoing destruction requests from Manufacturing, RD, QA and IPQA. Contact person for the reverse distributor. Have destruction pallets staged and ready to go.
10 Daily Provide access to Warehouse Vault and Cage at both DEA licensed Client manufacturing sites
15 Weekly QA/DEA representative for product transfer between facilities, providing DEA required documentation and witness
5
15 Quarterly Assist with ARCOS reporting for Distribution and 2 Client Manufacturing Licenses
5 Weekly Assist in Controlled Substance Batch Record Accountability Tracking.
5 Weekly Assist in issuance on DEA form 222, 236 and 486.
5 Weekly Aid in coordination and training of employees on DEA requirements and SOPs pertaining to DEA compliance and New Hire Training
10 Daily Oversee all departments' controlled substance inventories, YEI, Biennial Inventories and YERS.
 

OTHER FUNCTIONS AND RESPONSIBILITIES
This role will provide assistance to the DEA Manager, and will need to perform other duties as assigned.



Qualifications

QUALIFICATIONS REQUIRED/PREFERRED:
- Bachelor's Degree preferred or equivalent experience
- Previous pharmaceutical experience (generic experience preferred, but Brand Pharma is OK)
o 2-3 years of experience desired
- DEA experience in Pharma is highly desired – OR – educational equivalent.
- Knowledge of 21 CFR Part 1300-End
- GMP Knowledge is a must
- Computer proficiency; MS Office applications.
- Excellent record keeping and organization skills
- Ability to take initiative as issues arise
- Excellent verbal and written communication skills
- Solid analytical and problem-solving skills, critical-thinking and attention to detail
- Ability to meet accelerated timelines, and manage priorities