Cosmetics QA & Clinical Compliance Specialist

SGS; Union (NJ); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Online training courses

Tuition reimbursement

Job summary

SGS is seeking a Quality Assurance Specialist II for the Cosmetics and Hygiene line at the Union site. You will help standardize and harmonize the quality management system, conduct audits, and support regulatory reviews to ensure deliverables meet customer requirements.

The role includes clinical study monitoring and cross-functional collaboration across North America. This position requires a Bachelor’s in a relevant field and multiple years in QA and auditing, including experience with GCP,

Qualifications

• Bachelor’s degree required in one or more of the listed fields.
• 3+ years of experience 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 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 a quality management system for clinical trial studies on human subjects.
• Liaise with Operational leaders regarding changes to the Quality Manual for Union site.
• Participate in clinical study monitoring and audits, led internally or by sponsors.
• Oversee real-time reviews of clinical study documentation from start to finish and escalate non-conformances.
• Help meet study timelines by monitoring KPIs and collaborating with cross-functional teams.
• Create cross-training for North America QA to ensure qualified backup QA support.

Education

Bachelor’s degree in Biology or Microbiology, Chemistry or Biochemistry, Business Administration, Quality Assurance, Regulatory Compliance

Job description

SGS is seeking a Quality Assurance Specialist II for the Cosmetics and Hygiene line at the Union site. You will help standardize and harmonize the quality management system, conduct audits, and support regulatory reviews to ensure deliverables meet customer requirements.

The role includes clinical study monitoring and cross-functional collaboration across North America. This position requires a Bachelor’s in a relevant field and multiple years in QA and auditing, including experience with GCP,