Quality Assurance Specialist

SGS North America Inc.; Richardson (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

SGS North America Inc. is seeking a QA Specialist to ensure compliance with protocols, federal regulations, SOPs, and company procedures.

The role involves reviewing protocols, informed consents, CRFs, and study materials, auditing master files, source data, and training files, and coordinating with international teams to ensure accurate documentation for clients. The candidate will monitor internal studies, assist with CAPAs, and train new staff while upholding GCP/ICH guidelines and federal

Qualifications

• Bachelor's degree and 1–3 years of relevant experience in clinical trials or regulated environments.
• Knowledge of GCP/ICH/GLP guidelines and Federal regulations related to clinical trials.
• Ability to understand clinical studies and maintain protocol and regulatory documentation.

Responsibilities

• Ensure compliance with protocols, regulations, SOPs, and company procedures.
• Review protocols, informed consents, and case report forms prior to study initiation and revisions.
• Coordinate with international coordinators and project managers to ensure accurate documentation for clients.
• Review marketing and recruiting documentation for compliance.
• Audit study material receipt, return/destruction, and in-clinic procedures.
• Audit clinical trial master files, source data, and SOPs for GCP/ICH compliance.
• Review Final Reports and assist with auditing training files.
• Monitor internal studies and alternate sites; document non-conformities and corrective actions.
• Provide training to new departmental staff; collaborate with all involved parties.

Skills

GCP/ICH familiarity

Attention to detail

Organizational skills

Interpersonal skills

Multi-tasking

Education

Bachelor's degree

Job description

Full-timeCompany Description

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.

Job Description

• 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 documentsWorks 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.

Qualifications

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

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability