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 netw…
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 netw…
Skills: Equipment Calibration, Training Development, SOP Writing, Clinical Research, Interpersonal Communication
Coordenador(a) Técnico(a) de ESG, Sustentabilidade Corporativa e Assurance
Barueri, São Paulo, Brazil · On-site
Senior
Descrição da empresa 🚀 Junte-se à SGS – Líder Mundial em Inspeção, Testes e Certificação A SGS, multinacional suíça presente em mais de 140 países com mais de 99.600 colaboradores, busca profissionais que valorizem inov…
Descripción de la empresa SGS es líder mundial en inspección, verificación, análisis y certificación. Está considerada como principal referente mundial en calidad e integridad, contamos con más de 93.000 empleados y con …
Skills: Quality Management Systems, QA/QC Management, ISO 17025, ISO 9001, Statistical Process Control
Descripción de la empresa En SGS nuestra misión es aportar valor a la sociedad, proporcionando un entorno sostenible. Con nuestro trabajo garantizamos la seguridad y calidad, aportando confianza a todos los ámbitos de la…
Descripción de la empresa En SGS nuestra misión es aportar valor a la sociedad, proporcionando un entorno sostenible. Con nuestro trabajo garantizamos la seguridad y calidad, aportando confianza a todos los ámbitos de la…
Descripción de la empresa En SGS nuestra misión es aportar valor a la sociedad, proporcionando un entorno sostenible. Con nuestro trabajo garantizamos la seguridad y calidad, aportando confianza a todos los ámbitos de la…
Descripción de la empresa En SGS nuestra misión es aportar valor a la sociedad, proporcionando un entorno sostenible. Con nuestro trabajo garantizamos la seguridad y calidad, aportando confianza a todos los ámbitos de la…
Descripción de la empresa En SGS nuestra misión es aportar valor a la sociedad, proporcionando un entorno sostenible. Con nuestro trabajo garantizamos la seguridad y calidad, aportando confianza a todos los ámbitos de la…
Skills: Occupational Risk Prevention, Business Activity Coordination, Facility Inspections, English B2, Client Support
Company Description SGS is the world's leading inspection, verification, testing and certification company. We are recognised as the global benchmark for quality and integrity. With more than 89,000 employees, we operate…
Skills: Operational Leadership, Business Development, Client Relationship Management, HSE Risk Management, Quality Control
Descripción de la empresa En SGS nuestra misión es aportar valor a la sociedad, proporcionando un entorno sostenible. Con nuestro trabajo garantizamos la seguridad y calidad, aportando confianza a todos los ámbitos de la…
Skills: Electrical Inspections, Grounding System Measurement, Technical Reporting, Electronics, Electricity
Descripción de la empresa En SGS nuestra misión es aportar valor a la sociedad, proporcionando un entorno sostenible. Con nuestro trabajo garantizamos la seguridad y calidad, aportando confianza a todos los ámbitos de la…
Skills: Electrical Inspections, Grounding System Verification, Technical Reporting, Electronics, Electricity
Descripción de la empresa En SGS nuestra misión es aportar valor a la sociedad, proporcionando un entorno sostenible. Con nuestro trabajo garantizamos la seguridad y calidad, aportando confianza a todos los ámbitos de la…
Skills: Electrical Inspection, Grounding System Verification, Technical Reporting, Electronics, Electricity
Descripción de la empresa En SGS nuestra misión es aportar valor a la sociedad, proporcionando un entorno sostenible. Con nuestro trabajo garantizamos la seguridad y calidad, aportando confianza a todos los ámbitos de la…
Skills: High Voltage Inspection, Grounding System Measurement, Technical Reporting, Electronics, Electricity
ALTERNANCE - Animateur Q3SE H/F - Montoir de Bretagne (44)
Montoir-de-Bretagne, Pays de la Loire, France · On-site
Entry level
Description de l'entreprise Nous sommes SGS, le leader mondial du testing, de l’inspection et de la certification. Reconnue comme la référence en termes de qualité et d’intégrité, SGS exploite un réseau de plus de 2 650 …
Técnico/a de Medio Ambiente – Autorizaciones Ambientales Integradas (AAI)
Galicia, Spain · On-site
Mid level
Descripción de la empresa En SGS nuestra misión es aportar valor a la sociedad, proporcionando un entorno sostenible. Con nuestro trabajo garantizamos la seguridad y calidad, aportando confianza a todos los ámbitos de la…
Company Description SGS is the world’s leading Testing, Inspection and Certification company — the global benchmark for quality and integrity. With over 140 years of global expertise and a presence in Vietnam since 1989,…
Skills: Microbiology, Biotechnology, ISO 17025, Team Leadership, Root Cause Analysis
Starszy Specjalista / Starsza Specjalistka ds. deklaracji celnych
Biała Podlaska, Lubelskie, Poland · Hybrid
Mid level
Opis firmy SGS jest światowym liderem w dziedzinie badań, inspekcji i certyfikacji. Działamy w sieci ponad 2500 laboratoriów i biur w 115 krajach, wspieranych przez zespół ponad 100 000 oddanych swojej pracy profesjonali…
Skills: Data Entry, Customer Service, Documentation Management, Client Relationship Management, Knowledge Transfer
Starszy Specjalista / Starsza Specjalistka ds. deklaracji celnych
Biała Podlaska, Lubelskie, Poland · Hybrid
Mid level
Opis firmy SGS jest światowym liderem w dziedzinie badań, inspekcji i certyfikacji. Działamy w sieci ponad 2500 laboratoriów i biur w 115 krajach, wspieranych przez zespół ponad 100 000 oddanych swojej pracy profesjonali…
Skills: Data Entry, Customer Service, Documentation Management, Client Relationship Management, Knowledge Transfer
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$65k–$80k/yr
Full-time
bachelor degree
Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, Employee Assistance Programs, 401(k) With Company Match
Posted 31d ago
~40 hrs/week
Responsibilities
The specialist will standardize and improve the quality management system and perform internal audits according to ISO 19011 standards. They will primarily oversee clinical studies at the Union site to ensure compliance with regulatory requirements and customer deliverables.
Requirements
Requires a Bachelor's degree in a science or business field and at least 3 years of QA experience, including 2 years in a leadership role. Candidates must have experience in clinical monitoring and a background as a lead auditor or auditing team member.
Full 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
The Quality Assurance Specialist II, Cosmetics and Hygiene, assists with the standardization and harmonization, and continuous improvement of the quality management system, performs audits of internal processes according to ISO 19011 standards, support in regulatory audits, and remains knowledgeable of regulatory requirements and accreditation standards, including, but not limited to Good Clinical Practices, International Center for Harmonization, Food and Drug Administrations and ISO Standards.
May participate in developing policies, procedures and methods to evaluate and improve the quality of products, materials, components and/or operations. Will primarily oversee clinical studies performed at the SGS Cosmetic and Hygiene, Union Site and may support studies performed at other North America sites.
Ensure compliance with the requirements of a quality management system to demonstrate SGS’s ability to perform clinical trial studies on human subjects according to all applicable regulatory requirements and standards and ensure that deliverables consistently meet customer requirements.
Ensure SGS Cosmetics and Hygiene Quality Manual is always adhered to for activities performed at SGS Union site and liaise with the Operational leaders regarding changes to its design and implementation.
Actively participates in clinical study monitoring at SGS Union site along with active participation during audits that are led internally or by sponsors, or accreditation bodies.
Conducts routine oversight of ongoing clinical studies by conducting real time reviews of clinical study documentation from start to finish and timely escalations of events/non-compliances to management.
Ensure Study completion timelines are met by implementing and monitoring key performance indicators (KPIs) and by collaborating constantly with cross-functional teams and SMEs during day-to-day operations.
Self-motivated and agile to assess, organize competing priorities and execute tasks with utmost attention to Quality.
Create cross-training course list for North America QA to ensure qualified back-up QA support.
Qualifications
Bachelor’s degree in one or more of the following areas: Biology or Microbiology, Chemistry or Biochemistry, Business Administration, Quality Assurance, Regulatory Compliance, etc.
3+ years of experience as a Quality Assurance Processional and 2+ years of experience in a Quality Assurance or Operational Leadership role
Working knowledge of GCP, GDP, GLP and ICH E6 standards Required
1+ year of experience as a Lead Auditor, or 3+ years as support on an auditing team Required
2+ year of experience in clinical monitoring
Excellent working knowledge of Good Clinical Practices and regulatory systems [ISO, FDA, ICH], standards and compliance/auditing techniques
Additional Information
Our Benefits
We 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 program
Work-Life Balance: Paid-time off and family leave
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.
Compensation: USD 65000 - USD 80000 - yearly
Related keywords
CosmeticsHygieneQuality Management SystemISO StandardsFDAICHGCPGDPGLPClinical TrialsLead AuditorRegulatory ComplianceSGSClinical Study MonitoringQuality Manual