Quality Assurance Specialist
SGS · Richardson, Texas, US
Company Description We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainabil...
Job description
Company Description We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. Job Description: QA Specialist is responsible for ensuring compliance with protocols, federal regulations, industry guidelines and company procedures. Maintain knowledge of Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and Federal and applicable regulations. - Performs review of protocols, informed consents, and case reports forms (CRFs) prior to study initiation and revised documents - Works directly with international coordinators and project managers to ensure accurate documentation is performed for clients - Performs review of marketing and recruiting documentation - Performs audit of study material receipt and return/destruction - Performs in clinic audit of study procedures - Conducts audits of clinical trial master files, source data, and procedures for protocol, monitoring plan (when applicable) SOP, and GCP/ICH compliance -...