Quality Assurance Specialist II

About the role

We are SGS – the world's leading testing, inspection and certification company, recognized as the global benchmark for sustainability, quality and integrity. The Quality Assurance Specialist II, Cosmetics and Hygiene, assists with the standardization, harmonization, and continuous improvement of the quality management system. This role performs audits of internal processes according to ISO 19011 standards, supports regulatory audits, and remains knowledgeable of regulatory requirements and accreditation standards, including Good Clinical Practices, International Center for Harmonization, Food and Drug Administration, and ISO Standards.

You will primarily oversee clinical studies performed at the SGS Cosmetics and Hygiene, Union Site and may support studies at other North America sites. The role ensures compliance with quality management system requirements to demonstrate SGS’s ability to perform clinical trial studies on human subjects according to all applicable regulatory requirements and standards, ensuring deliverables consistently meet customer requirements.

Responsibilities

• Ensure adherence to the SGS Cosmetics and Hygiene Quality Manual for activities performed at the SGS Union site and liaise with operational leaders regarding changes to its design and implementation.
• Actively participate in clinical study monitoring at the SGS Union site, including during audits led internally, by sponsors, or accreditation bodies.
• Conduct routine oversight of ongoing clinical studies by performing real-time reviews of clinical study documentation from start to finish and escalating events/non-compliances to management in a timely manner.
• Ensure study completion timelines are met by implementing and monitoring key performance indicators (KPIs) and collaborating with cross-functional teams and subject matter experts (SMEs) during day-to-day operations.
• Assess, organize, and prioritize competing tasks with a strong focus on quality.
• Create a cross-training course list for North America Quality Assurance to ensure qualified back-up QA support.
• May participate in developing policies, procedures, and methods to evaluate and improve the quality of products, materials, components, and/or operations.

Requirements

• Bachelor’s degree in one or more of the following areas: Biology or Microbiology, Chemistry or Biochemistry, Business Administration, Quality Assurance, or Regulatory Compliance.
• 3+ years of experience as a Quality Assurance Professional and 2+ years of experience in a Quality Assurance or Operational Leadership role.
• Working knowledge of GCP, GDP, GLP, and ICH E6 standards.
• 1+ year of experience as a Lead Auditor, or 3+ years as support on an auditing team.
• 2+ years of experience in clinical monitoring.
• Excellent working knowledge of Good Clinical Practices, regulatory systems (ISO, FDA, ICH), standards, and compliance/auditing techniques.

Benefits

We care about your total well-being and offer the following benefits, subject to your location and role:

• Health: Medical, dental, and vision insurance; life insurance; employee assistance programs.
• Wealth: 401(k) with company match (immediate vesting upon enrollment).
• Happiness: Paid-time off and family leave.
• Professional Growth: Online training courses, virtual and classroom development experiences, tuition reimbursement program.