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Quality Assurance Manager

2 months ago


New York, New York, United States Hartmann Young Full time

Job Summary:

Hartmann Young is seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for maintaining all administrative controlled substances activities, including reports and quotas, and ensuring compliance with regulatory requirements.

Key Responsibilities:

  • Coordinate and maintain all controlled substance certificates
  • Prepare and review all DEA reportable documentation
  • Develop and implement procedures related to DEA compliance
  • Develop and implement procedures related to OSHA compliance
  • Provide QA support and coverage in the GMP manufacturing area
  • Assist in company regulatory inspections and conduct internal and external audits
  • Audit vendors, contractors, and contract research organizations
  • Maintain vendors certification program
  • Develop and maintain written standard operating procedures

Requirements:

  • Bachelor's Degree in a science-related field (Associates degree considered)
  • Proficiency in Microsoft Word and Microsoft Excel
  • Excellent communication and writing skills