Quality Assurance Specialist

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