Quality Assurance Specialist

About the role

SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services. Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.

Responsibilities

• Performs review of protocols, informed consents, and case reports forms (CRFs) prior to study initiation and revised documents
• Performs audits of internal departments as required.
• 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 monitoring of study procedures per associate clinical study
• 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 sponsor Final Report
• Assists with auditing the company training files
• Monitors internal studies and alternative sites
• Assist with documentation of root-cause analysis stemming from internal non-conformities, corrective actions, and preventive actions
• Assist in the review of clinical study protocol deviations
• Training of new departmental staff
• Work with all involved parties to ensure that both the equipment and operational needs are met

Qualifications

• Associates and min of 2 –4 years of relevant experience
• 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
• Preferred: ISO 19011 Internal Auditing Training- preferred