QA Specialist II - Cosmetics & Clinical Compliance

SGS; Union (NJ); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Online training courses

Tuition reimbursement

Paid time off

Family leave

Job summary

SGS Union site in New Jersey is seeking a Quality Assurance Specialist II for Cosmetics and Hygiene. The role supports standardization, harmonization and continuous improvement of the quality management system and conducts audits per ISO 19011.

You will oversee clinical studies at the Union site, participate in internal and sponsor audits, monitor documentation, and escalate issues promptly while collaborating with cross-functional teams to meet timelines and KPIs.

Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry or related field.
• 3+ years in Quality Assurance.
• 2+ years QA or Operational Leadership.
• GCP experience; GDP, GLP and ICH E6 are assets.
• Lead Auditor: 1+ year or 3+ years on an auditing team.
• 2+ years in clinical monitoring.
• Strong knowledge of GCP and regulatory systems (ISO, FDA, ICH).

Responsibilities

• Ensure compliance with the quality management system for clinical trial studies.
• Oversee SGS Union site QA activities and liaise with operational leaders.
• Actively participate in clinical study monitoring and audits.
• Real-time review of study documentation with timely escalation of issues.
• Meet study timelines by monitoring KPIs and collaborating with cross-functional teams.
• Create cross-training materials for North America QA.

Skills

Quality Assurance

Clinical monitoring

Auditing

Regulatory compliance

Education

Bachelor's degree in Biology / Microbiology / Chemistry / Biochemistry

Job description

SGS Union site in New Jersey is seeking a Quality Assurance Specialist II for Cosmetics and Hygiene. The role supports standardization, harmonization and continuous improvement of the quality management system and conducts audits per ISO 19011.

You will oversee clinical studies at the Union site, participate in internal and sponsor audits, monitor documentation, and escalate issues promptly while collaborating with cross-functional teams to meet timelines and KPIs.