Job Title: Associate, R&D Quality Assurance
Summary of Key Responsibilities
- Prepare annual risk assessments for GCP vendors and internal audits which establishes the annual audit plan.
- Assist in the audit planning process, including auditor selection, audit agenda, conduct, and report writing
- Assist in ensuring proper CAPA management and closure for audit deliverables.
- Review and assess new vendor request and determine appropriate audit strategy.
- Support the development, implementation, and maintenance of GCP auditing policies and programs, as well as appropriate GxP requirements
- Educated to bachelor's degree level, preferably life science (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience.
- At least 1-3 years' experience in GCP Quality Auditing, or similar experience working in GCP and clinical trial that support pharmaceutical development.
- Experience working with Clinical Operations, Quality Assurance, Regulatory Affairs, Auditing, Clinical Research, Monitoring, Data Management, Pharmacy, Laboratory, or other relevant area, including applicable GxP auditing.
- Strong working knowledge in GCP regulations and guidance for FDA and International agencies including ICH guidelines.
- If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required