Quality Assurance Specialist

SGS•Richardson, TX

About The Position

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. 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 Performs review of Final Report Assists with auditing the company training files Monitors internal studies and alternative sites Assist with documentation of non-conformities, corrective actions, and preventive actions Critical in training of new departmental staff Other duties or tasks assigned by manager Work with all involved parties to ensure that both the equipment and operational needs are met. Oversee that the lab safety and orderly contact and take prompt corrective action when unsafe conditions, practices, or equipment are reported or observed. Encourage prompt reporting of health and safety concerns.

Requirements

Bachelor’s and min 1-3 years of relevant experience
Demonstrated ability to understand clinical studies
Excellent organizational, attention to detail, interpersonal skills, and possesses a high level of multi-tasking capacities
Knowledge of GCP ICH/GLP guidelines and Federal Regulations related to the conduct of Clinical Trails, NIH training

Responsibilities

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
Performs review of Final Report
Assists with auditing the company training files
Monitors internal studies and alternative sites
Assist with documentation of non-conformities, corrective actions, and preventive actions
Critical in training of new departmental staff
Other duties or tasks assigned by manager
Work with all involved parties to ensure that both the equipment and operational needs are met.
Oversee that the lab safety and orderly contact and take prompt corrective action when unsafe conditions, practices, or equipment are reported or observed.
Encourage prompt reporting of health and safety concerns.