Quality Assurance Specialist

About the role

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.

The 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.

Responsibilities

• Performs review of protocols, informed consents, and case report 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
• Assists with documentation of non-conformities, corrective actions, and preventive actions
• Critical in training of new departmental staff
• Other duties or tasks assigned by manager
• Works with all involved parties to ensure that both the equipment and operational needs are met
• Oversees lab safety and orderly conduct, taking prompt corrective action when unsafe conditions, practices, or equipment are reported or observed
• Encourages prompt reporting of health and safety concerns

Requirements

• Bachelor’s degree
• Minimum 1-3 years of relevant experience
• Demonstrated ability to understand clinical studies
• Excellent organizational, attention to detail, and interpersonal skills
• High level of multi-tasking capacity
• Knowledge of GCP ICH/GLP guidelines and Federal Regulations related to the conduct of Clinical Trials
• NIH training