Compliance Manager

Opportunity Description

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.

Company Information

Specialty pharmaceuticals

Job Duties

• Coordinates the DEA Systems to assure compliance to procedures and regulations.
• Maintains running reconciliation for inspection purposes.
• Hosts DEA Inspections
• Prepares all DEA reportable documentation-Arcos, Quota, UN, Bienniel, CSOS, Import / Export
• Prepares or reviews and approves all procedures related to DEA compliance.
• Trains company employees in DEA regulations
• 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.

Education

Bachelor’s Degree preferred in a science-related field.

Experience & Skills Required

• Prior experience with DEA of Similar scope a Must
• Proficiency in the use of software including Microsoft Word and Microsoft Excel.
• Good communication and writing skills.