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Quality Assurance Specialist

2 months ago

Sanford, North Carolina, United States Integrated Resources, Inc ( IRI ) Full time

Job Summary:

We are seeking a highly skilled Quality Assurance Specialist to join our team at Integrated Resources, Inc. (IRI). As a key member of our Quality Operations department, you will be responsible for ensuring the quality of our suppliers and materials.

Key Responsibilities:

  • Support the Quality Operations department by performing Quality Assurance activities, including supplier qualification and management, and enrollment of new materials and suppliers.
  • Conduct regulatory agency inspections and audits to ensure compliance with industry standards.
  • Perform QA assessments and approvals for supplier management, including risk assessments and quality agreements.
  • Contribute to the interpretation of cGXP regulations for the commercial and clinical environment.
  • Develop and implement new processes and programs for quality improvement.
  • Interface with other departments, including research and development, to ensure seamless quality operations.
  • Represent Quality Assurance in cross-functional meetings and summits.

Requirements:

  • Bachelor's or Master's degree in a science-related field or equivalent education and/or pharmaceutical work experience.
  • Knowledge of cGXP regulations, materials, components, and supplier management.

Technical Competencies:

  • Proficiency in GMP Systems and MS Office.

Resources Managed:

  • Continuous improvement of processes.
  • No direct reports.