Quality Assurance Specialist

SGS; Richardson (TX); On-site; USD 60,000 - 85,000; Full time

Job summary

A global testing and certification leader is seeking a QA Specialist in Richardson, Texas. The ideal candidate will ensure compliance with protocols and federal regulations while reviewing clinical study documents. Required qualifications include a Bachelor’s degree and 1-3 years of relevant experience, with strong organizational and interpersonal skills. The role involves auditing clinical procedures and assisting in training new staff, contributing to maintaining high standards in quality assurance.

Qualifications

• 1-3 years of relevant experience in QA or clinical studies.
• Ability to understand and interpret clinical studies.
• Knowledge of GCP ICH/GLP guidelines and Federal Regulations related to Clinical Trials.

Responsibilities

• Ensure compliance with protocols and federal regulations.
• Perform audit of study procedures and documentation.
• Conduct training for new departmental staff.
• Review clinical study materials and documentation.

Skills

Excellent organizational skills

Attention to detail

Interpersonal skills

Multi-tasking capabilities

Education

Bachelor’s degree

Job 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 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
• 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.