Quality Assurance Specialist

About the Company

SGS is a global leader in testing, inspection, and certification services, known for setting the standard in sustainability, quality, and integrity. With a workforce of 99,600 people across 2,600 offices and laboratories, the organization works to support a safer, better-connected world.

Role Overview

The Quality Assurance Specialist is accountable for making sure studies, records, and processes follow required protocols, federal rules, industry guidance, and internal procedures. The role requires working knowledge of Good Clinical Practices (GCP), Standard Operating Procedures (SOPs), and relevant federal regulations.

Key Responsibilities

• Review protocols, informed consent forms, and case report forms before study launch and whenever documents are updated.
• Coordinate with international coordinators and project managers to ensure client documentation is completed accurately.
• Check marketing and recruitment materials for compliance and accuracy.
• Audit the receipt, storage, return, and destruction of study materials.
• Carry out on-site clinic audits of study procedures.
• Examine clinical trial master files, source records, and procedures for alignment with the protocol, monitoring plan when applicable, SOPs, and GCP/ICH requirements.
• Review final reports for completeness and correctness.
• Support audits of employee training records.
• Monitor internal studies and alternate sites.
• Help document non-conformities, corrective actions, and preventive actions.
• Assist in training new team members within the department.
• Take on additional tasks as assigned by the manager.
• Work with stakeholders to ensure equipment and operational needs are met.
• Help maintain a safe and orderly laboratory environment and take quick corrective action when unsafe conditions, practices, or equipment are identified.
• Encourage timely reporting of safety concerns.

Qualifications

Candidates should hold a bachelor’s degree and bring 1 to 3 years of relevant experience. The role calls for the ability to understand clinical studies, strong organization, sharp attention to detail, solid interpersonal skills, and the capacity to handle multiple tasks effectively. Knowledge of GCP, ICH, GLP guidelines, federal rules tied to clinical trials, and NIH training is required.

Additional Information

SGS is committed to equal opportunity hiring. The company recruits, hires, trains, and promotes individuals without discrimination based on race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, protected veteran status, or any other protected characteristic.

To succeed in this position, an employee must be able to carry out each essential duty satisfactorily, with or without reasonable accommodation. The qualifications listed are intended to reflect the knowledge, skills, and abilities needed for the role.

This description is not exhaustive and may not include every duty, responsibility, or requirement. SGS reserves the right to assign or change job duties and responsibilities at any time.

If you are applying for a role in the United States and need help completing the online employment application because of a disability, you may call 201-508-3149 and leave a message for assistance. This number is only for applicants who need support due to a disability and is not for general employment inquiries.