What are the responsibilities and job description for the Clinical Quality Specialist position at Astrix?
Quality Assurance Specialist
About the Role:
We’re looking for a Quality Assurance Specialist to support the Global R&D Quality Assurance team. This role ensures research studies meet GLP and GCP compliance standards, playing a key role in regulatory submissions. You’ll review study data and help maintain high-quality compliance for animal health research.
Key Responsibilities:
- Review protocols, amendments, data, and reports for GLP and GCP animal health studies, including bioanalytical studies.
- Conduct audits and issue audit reports to study monitors, study directors, investigators, and management.
- Track audit findings, review responses, and ensure corrective actions are documented appropriately.
- Assist in internal facility inspections at research sites and issue reports to management.
- Ensure study data is collected, documented, and reported in compliance with GLP/GCP regulations, study protocols, SOPs, and industry standards.
Qualifications:
- Bachelor’s degree with at least 2 years of GLP auditing experience in an R&D regulatory compliance environment or 3 years of relevant experience.
- Quality Assurance experience in R&D or GLP data review.
- Experience working in a GLP environment.
- Strong communication, organization, and writing skills.
- Ability to manage multiple tasks effectively.
Not Seeking Experience In:
- GMP Auditing
This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
