What are the responsibilities and job description for the Quality Assurance Specialist position at Technical Resources International, Inc.?
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.
- 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.