QA Specialist (Clinical Trials)

Location: Richardson, Texas, USA; full-time onsite role

Company

SGS is a global testing, inspection, and certification company focused on sustainability, quality, and integrity.

What you will do

• Review protocols, informed consents, case report forms, marketing materials, recruiting documents, and final reports.
• Audit study material receipt and return or destruction, in-clinic procedures, clinical trial master files, source data, and protocol documentation.
• Work with international coordinators and project managers to ensure accurate client documentation.
• Monitor internal studies and alternative sites while verifying compliance with monitoring plans, SOPs, GCP, and ICH requirements.
• Document non-conformities and support corrective and preventive actions.
• Train new departmental staff and help ensure equipment, operational, and laboratory safety needs are met.

Requirements

• Bachelor’s degree and 1–3 years of relevant experience.
• Ability to understand clinical studies and clinical trial processes.
• Knowledge of GCP, ICH, GLP guidelines, SOPs, NIH training, and applicable federal regulations.
• Strong organization, attention to detail, interpersonal skills, and multitasking ability.
• Ability to identify and promptly address unsafe laboratory conditions, practices, or equipment.

Culture & Benefits

• Work within a global network of testing, inspection, and certification offices and laboratories.
• Equal opportunity employment and consideration for reasonable accommodations.
• Full-time employment based in Richardson, Texas.