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SGS
Quality and Regulatory Specialist - Flamability Lab
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Job Description
Company DescriptionSGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.
Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.
Job DescriptionPosition SummaryQuality 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.
JOB FUNCTIONSPerforms review of protocols, informed consents, and case reports forms (CRFs) prior to study initiation and revised documentsReview company policies and procedures to ensure they meet regulatory standardsCollaborate with operational teams to ensure regulatory compliance is considered during the design process and scope of deliveryPreparing and submitting documentation to regulatory agencies and accrediting bodies, as neededKeeping up-to-date with changes in regulatory legislation, guidelines, and industry standardsMonitoring and setting standards for quality controlInvestigating and setting standards for safety and healthAssessing outcome, compliance, or operational risks and developing risk management strategiesConducting internal audits to measure and assure adherence to established QA standards in accordance with applicable regulations and guidelinesTraining staff and team members about quality, regulatory, and compliance issuesMaintaining and organizing necessary documentationAddressing non-compliance issuesWorks directly with international coordinators and project managers to ensure accurate documentation is performed for clientsConducts audits of clinical trial master files, source data, and procedures for protocol, monitoring plan (when applicable) SOP, and GCP/ICH complianceAssists with auditing the company training filesAssist with documentation of root-cause analysis stemming from internal non-conformances, corrective actions, and preventive actionsAssist in the review of clinical study protocol deviationsTraining of new departmental staffOther duties or tasks assigned by manager or supervisorEncourage prompt reporting of health and safety concerns.
Qualifications
Good organizational/time management skills.
Familiarity with with Jurisdictional / ISO requirementsAdditional InformationCompensationThe expected salary for this position is $28.00 to $35.00 per hour. This range represents the minimum and maximum base salary we reasonably expect to pay for this role. Actual compensation within the range will depend on skills, experience, and qualifications.
Our BenefitsWe care about your total well-being and will support you with the following, subject to your location and role.
Position anticipated to close August 31, 2026.Additional informationSGS 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 callback. 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.
Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.
Job DescriptionPosition SummaryQuality 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.
JOB FUNCTIONSPerforms review of protocols, informed consents, and case reports forms (CRFs) prior to study initiation and revised documentsReview company policies and procedures to ensure they meet regulatory standardsCollaborate with operational teams to ensure regulatory compliance is considered during the design process and scope of deliveryPreparing and submitting documentation to regulatory agencies and accrediting bodies, as neededKeeping up-to-date with changes in regulatory legislation, guidelines, and industry standardsMonitoring and setting standards for quality controlInvestigating and setting standards for safety and healthAssessing outcome, compliance, or operational risks and developing risk management strategiesConducting internal audits to measure and assure adherence to established QA standards in accordance with applicable regulations and guidelinesTraining staff and team members about quality, regulatory, and compliance issuesMaintaining and organizing necessary documentationAddressing non-compliance issuesWorks directly with international coordinators and project managers to ensure accurate documentation is performed for clientsConducts audits of clinical trial master files, source data, and procedures for protocol, monitoring plan (when applicable) SOP, and GCP/ICH complianceAssists with auditing the company training filesAssist with documentation of root-cause analysis stemming from internal non-conformances, corrective actions, and preventive actionsAssist in the review of clinical study protocol deviationsTraining of new departmental staffOther duties or tasks assigned by manager or supervisorEncourage prompt reporting of health and safety concerns.
Qualifications
EDUCATION AND
EXPERIENCEHigh School Diploma or equivalent (Required)Engineering Technology Diploma (Preferred)Minimum 5 years relevant experience (Required)Supervisory experience is an asset (Preferred)KNOWLEDGE / SKILLS
/ ABILITIESAbility to manage and coordinate multiple projects in a fast-paced, highly professional environment.Good organizational/time management skills.
Familiarity with with Jurisdictional / ISO requirementsAdditional InformationCompensationThe expected salary for this position is $28.00 to $35.00 per hour. This range represents the minimum and maximum base salary we reasonably expect to pay for this role. Actual compensation within the range will depend on skills, experience, and qualifications.
Our BenefitsWe care about your total well-being and will support you with the following, subject to your location and role.
Health:
Medical, dental and vision insurance, life insurance, employee assistance programs.Wealth:
In addition to base pay, we offer 401(k) with company match (immediate vesting upon enrollment).Happiness:
Professional Growth:
Online training courses, virtual and classroom development experiences, tuition reimbursement programWork-Life Balance:
Paid-time off and family leaveIn compliance with applicable state and local pay transparency laws, we provide clear and equitable compensation information for all applicants.Position anticipated to close August 31, 2026.Additional informationSGS 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 callback. 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.