POSITION:
QA & DEA Compliance Coordinator 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.
DUTIES:
- Coordinates the DEA Systems to assure compliance to procedures and regulations.
- Prepares all DEA reportable documentation.
- Prepares or reviews and approves all procedures related to DEA compliance.
- Prepares or reviews and approves all procedures related to OSHA compliance.
- Perform duties of the QA & Compliance Associates as required.
- Provides QA support and coverage in the GMP manufacturing area
- Assists in company regulatory inspections as well as conducting internal and external audits.
- Audits vendors, contractors, and contract research organisations
- Maintain vendors certification program
- Assists in establishing written standard operating procedures for the company and maintains and reviews written standard operating procedures.
QUALIFICATIONS:
- Bachelor’s Degree preferred in a science-related field preferred, however, Associates degree will be considered.
- Proficiency in the use of software including Microsoft Word and Microsoft Excel.
- Good communication and writing skills.
