Quality Assurance Specialist

Job Summary

A company is looking for a Quality Assurance Specialist responsible for supporting global quality assurance services and ensuring compliance with regulatory standards.

Key Responsibilities

• Implement quality assurance plans and processes, conducting audits and assessments
• Oversee the development of Quality System documents and train junior QA staff
• Plan and facilitate Sponsor and regulatory inspections, addressing audit findings

Required Qualifications

• Undergraduate degree with 4-6 years of related experience or College Diploma with 7-9 years of related experience
• Preferred background in Life Sciences, Clinical Research, Information Technology, or Clinical Quality Assurance
• Strong understanding of ICH GCP and global regulations governing Clinical Research
• Knowledge of global privacy regulations