Quality and Regulatory Specialist I - Hybrid at SGS North America Inc. in Richardson, Texas
Posted in Other 1 day ago.
Job Description:
Company 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
Quality and Regulatory Specialist is responsible for ensuring compliance with quality standards, federal regulations, industry guidelines and company procedures. Maintain knowledge of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), ISO 17025:2017, 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
- Review company policies and procedures to ensure they meet regulatory standards
- Collaborate with operational teams to ensure regulatory compliance is considered during the design process and scope of delivery
- Preparing and submitting documentation to regulatory agencies and accrediting bodies, as needed
- Keeping up-to-date with changes in regulatory legislation, guidelines, and industry standards
- Monitoring and setting standards for quality control
- Investigating and setting standards for safety and health
- Assessing outcome, compliance, or operational risks and developing risk management strategies
- Conducting internal audits to measure and assure adherence to established QA standards in accordance with applicable regulations and guidelines
- Training staff and team members about quality, regulatory, and compliance issues
- Maintaining and organizing necessary documentation
- Addressing non-compliance issues
- Works directly with international coordinators and project managers to ensure accurate documentation is performed for clients
- Conducts audits of clinical trial master files, source data, and procedures for protocol, monitoring plan (when applicable) SOP, and GCP/ICH compliance
- Assists with auditing the company training files
- Assist with documentation of root-cause analysis stemming from internal non-conformances, corrective actions, and preventive actions
- Assist in the review of clinical study protocol deviations
- Training of new departmental staff
- Other duties or tasks assigned by manager or supervisor
- Encourage prompt reporting of health and safety concerns.
Qualifications
- Associates and min of 2 -4 years of relevant experience - Required
- Bachelor's and min 1-3 years of relevant experience - Required
- Possible time in role before progressing 12-24 months - Required
- Demonstrated ability to understand clinical studies and the requirements from the regulating or accrediting bodies. - Required
- Excellent organizational, attention to detail, interpersonal skills, and possesses a high level of multi-tasking capacities - Required
- Knowledge of GCP ICH/GLP guidelines, ISO 17025:2017, ISO 19011, ISO 9001, and Federal Regulations related to the conduct of Clinical Trails, NIH training - Required
- ISO 19011 Internal Auditing Training- Preferred
KNOWLEDGE / SKILLS / ABILITIES
- Language Skills: English Required
- Computer Skills: Proficient with Microsoft Office applications
- Strong attention to detail and organizational, verbal and written communication and interpersonal skills
WORK SCHEDULE
This role offers a hybrid work arrangement, with three days spent on-site at the Richardson office and two days working remotely. The working hours are scheduled from 8:30 AM to 5:00 PM.
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.
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