Quality Assurance Specialist
Technical Resources International, Inc.
Summary
This role is fully remote for those living in the DMV area.
Job description
Job Description
- Supports the maintenance and upkeep of the Quality Management System.
- Maintains the Quality Assurance (QA) training program, document control, customer complaint program and CAPA program.
- Supports audits of clinical sites and vendors/suppliers.
- Supports internal audit program and performance metrics system for continual improvement.
- Manages the review cycle of QA controlled documents to assure practices reflect written procedures.
- Supports regulatory agency audits.
Job Requirements
- Knowledge of current GCP regulations.
- Experience in working with regulatory agency audits.
- Experience in working with Quality Systems for CROs.
- Excellent written/verbal communication skills.
- Proficiency in MS Office.
- Travel up to 15% (domestic and international)
This role is fully remote for those living in the DMV area.
Requirements
- Knowledge of current GCP regulations
- Experience in working with regulatory agency audits
- Experience in working with Quality Systems for CROs
- Excellent written/verbal communication skills
- Proficiency in MS Office
- Travel up to 15% (domestic and international)
Company overview
Technical Resources International, Inc. (TRI) is a leading contract research organization plus (CRO+) founded in 1979 and headquartered in Bethesda, Maryland. As a certified Hispanic woman-owned business, TRI provides comprehensive product development support services to pharmaceutical, biotechnology, vaccine, medical device, and healthcare sector clients worldwide. The company specializes in the effective integration of scientific, clinical, information technology, and communication services to accelerate drug development and regulatory approval processes. TRI offers end-to-end solutions including clinical trial management across all phases (I-IV), regulatory strategy and operations, biostatistics, data management, medical writing, and safety monitoring. With over four decades of experience, TRI has established itself as a trusted partner to both public and private sector clients, including major government agencies like the National Institutes of Health (NIH) and National Cancer Institute. The company's success is built on its staff's scientific expertise, client-focused approach, and proven track record of delivering high-quality services that meet regulatory standards and accelerate time-to-market for innovative therapies.