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Technical Resources International, Inc.
PRINCIPAL, QA
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Job Description
PRINCIPAL, QA
- Verifies GCP compliance to applicable Standard Operating Procedures (SOPs) and regulations
- Conducts audits of clinical sites and vendors/suppliers
- Provides full support to the Quality Management System
- Conduct external audits at clinical sites and vendor sites
- Leads process improvement activities and CAPA investigations
- Reviews clinical quality management plans and provides consultative support to clinical sites (as applicable.
- Trains junior staff on regulations and quality processes
- Supports regulatory authority inspections
- Supports business development activities, as requested Job Requirements
- Strong knowledge of current GCP regulations
- Experience with regulatory authority inspections
- Experience working with Quality Systems for CROs
- Experience conducting GCP clinical site audits
- Excellent written/verbal communication skills
- Proficiency in MS Office We are equal opportunity/affirmative action employers, committed to diversity in the workplace.