Technical Resources International, Inc.
Posted 2 days agoVerified live 1d ago
Quality Assurance Specialist
Brief overview
Remote
UndergradOr in progress
$70k–$85k/yrStated range
3+ yrsMinimum
Clinical Practice (GCP) RegulationsRegulatory Agency AuditsMicrosoft Office
About the company
Technical Resources International, Inc.tech-res.com
Technical Resources International is a pharmaceuticals company offering biostatistics and clinical data management services.
Job description
Summary
Technical Resources International, Inc. is hiring a Quality Assurance Specialist to support quality operations. The role maintains the Quality Management System, training, document control, complaint and CAPA programs, and supports clinical site, vendor, internal, and regulatory audits.
Responsibilities
- 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
Skills
- 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
Qualifications
Must Haves
- 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
Benefits
- This role is fully remote for those living in the DMV area.
More jobs like this
