Cosmetics QA Auditor – Clinical Trials & Compliance

SGS; Union (NJ); On-site; USD 59,000 - 72,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Tuition reimbursement

Job summary

SGS is seeking a Quality Assurance Specialist II for the Cosmetics and Hygiene division at the Union site in New Jersey. The role focuses on standardizing and improving the quality management system, conducting audits per ISO 19011, and supporting regulatory audits to ensure compliance with GCP, ISO, FDA, ICH standards.

The position involves overseeing clinical studies, monitoring study documentation, and collaborating with cross-functional teams to meet KPIs and timelines while fostering QA

Qualifications

• Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Business Administration, QA or Regulatory Compliance.
• 3+ years as a Quality Assurance Professional and 2+ years in a QA or Operational Leadership role.
• Experience in a GCP environment; GDP, GLP and ICH E6 are strong assets.
• 1+ year as Lead Auditor or 3+ years on an auditing team.
• 2+ years in clinical monitoring.
• Excellent working knowledge of Good Clinical Practices and regulatory systems (ISO, FDA, ICH).

Responsibilities

• Ensure compliance with QMS requirements to demonstrate SGS’s ability to perform clinical trial studies on human subjects.
• Adhere to the SGS Cosmetics and Hygiene Quality Manual for activities at the Union site and coordinate changes with Operational leaders.
• Participate in clinical study monitoring and internal or sponsor/auditor-led audits.
• Oversee ongoing clinical studies with real-time document reviews and timely escalation of events/non-compliances.
• Ensure study timelines are met by tracking KPIs and collaborating with cross-functional teams.
• Be self-motivated and agile to manage competing priorities with high quality.
• Create cross-training course lists for North America QA for back-up support.

Skills

Quality Assurance

Auditing

Clinical Monitoring

Regulatory Compliance

Education

Bachelor’s degree

Job description

SGS is seeking a Quality Assurance Specialist II for the Cosmetics and Hygiene division at the Union site in New Jersey. The role focuses on standardizing and improving the quality management system, conducting audits per ISO 19011, and supporting regulatory audits to ensure compliance with GCP, ISO, FDA, ICH standards.

The position involves overseeing clinical studies, monitoring study documentation, and collaborating with cross-functional teams to meet KPIs and timelines while fostering QA