Quality Assurance Manager

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.