Quality and Regulatory Specialist I - Hybrid

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 uptodate 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 noncompliance 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 rootcause analysis stemming from internal nonconformances 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
• Bachelors and min 13 years of relevant experience  Required
• Possible time in role before progressing 1224 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 multitasking 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 onsite 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 companys rights to assign or reassign duties and responsibilities to this job at any time.

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Remote Work :

Yes

Employment Type :

Fulltime