Job Description
POSITION:
DEA Compliance Manager for a Specialty Pharmaceutical Company.
JOB PURPOSE:
The QA & DEA Compliance Coordinator is responsible for maintaining all administrative controlled substances activities, including all reports and quotas, maintain all controlled substance certificates, performs duties of the QA & compliance associates as required. Reports to Senior Manager of Quality Assurance.
Primary Duties:
- Coordinates the DEA Systems at Elite Pharmaceuticals to assure compliance to procedures and regulations.
- Maintains running reconciliation for inspection purposes
- Hosts DEA Inspections
- Prepares all DEA reportable documentation:
- Arcos;
- Quota;
- UN;
- Biennial;
- CSOS;
- Import / Export.
- Prepares or reviews and approves all procedures related to DEA compliance.
- Trains company employees in DEA regulations
Ancillary Duties
- Perform duties for QA as required:
- Assists in company regulatory inspections as well as conducting internal and external audits;
- Audits vendors, contractors, and contract research organizations;
- Maintain vendors certification program.
QUALIFICATIONS:
- Bachelor’s Degree preferred in a science-related field
- Prior experience with DEA of similar scope is a must
- Proficiency in the use of software including Microsoft Word and Microsoft Excel.
- Good communication and writing skills.
Located in Bergen County, Northvale, New Jersey.
We offer a competitive salary and benefits package.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Experience:
- FDA regulations: 1 year (Preferred)
Ability to Relocate:
- Northvale, NJ 07647: Relocate before starting work (Required)
Work Location: In person