Pharmaceutical Quality Assurance Specialist

5 days ago


Sacramento, California, United States Nivagen Pharmaceuticals Full time
About the Role

We are seeking a skilled Pharmaceutical Quality Assurance Specialist to join our team at Nivagen Pharmaceuticals. This role is responsible for supporting the development, implementation, and maintenance of our Quality Management System (QMS) in compliance with regulatory requirements and industry standards.

The ideal candidate will have a strong understanding of pharmaceutical regulations, including FDA, EMA, GMP, and ICH guidelines. They will be proficient in data analysis and able to interpret complex quality data to identify trends and areas for improvement.

Key responsibilities include:

  • Maintaining and continually improving the QMS to ensure compliance with regulatory standards
  • Managing QMS documentation, including SOPs, quality manuals, and other controlled documents
  • Coordinating change controls to evaluate and document changes affecting the QMS
  • Analyzing quality data from various sources to identify trends and areas for improvement
  • Generating detailed reports on QMS performance metrics

Salary: $80,000 - $90,000 per year



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