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Quality Assurance Associate

2 months ago

Durham, North Carolina, United States Pharpoint Research Full time
Job Summary

We are seeking a highly skilled Quality Assurance Associate to join our team at PharPoint Research. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our operations.

Key Responsibilities
  • Maintain personnel training files and develop training programs to ensure compliance with SOPs and regulatory requirements.
  • Generate and review SOPs, Quality Manual, and Quality Action Plans to ensure alignment with industry standards.
  • Test usability and quality impact of potential products and provide ongoing QA support as needed.
  • Validate computer systems and carry out change control procedures to ensure data integrity.
  • Conduct vendor audits and internal audits to ensure compliance with PharPoint's Quality System.
  • Defend external audits and assist in regulatory inspections to ensure compliance with industry regulations.
Requirements
  • Bachelor's degree in a scientific, computer, or related discipline, or equivalent experience.
  • Minimum 1 year experience in quality assurance, quality control, and/or validation.
  • Knowledge of ICH Guidelines for Good Clinical Practice, Title 21 of the Code of Federal Regulations, and good industry practices involving Quality.
  • Ability to read, write, speak, and understand English required.
Work Environment

This is a full-time position in a general office environment with occasional domestic/international travel required.

Equal Employment Opportunity

PharPoint Research is an equal employment opportunity employer and welcomes applications from qualified candidates without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.