Quality Assurance Specialist II - GCP

Quality Assurance Specialist II - GCPWe 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 DescriptionThe 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.QualificationsBachelor'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 roleMust have experience working in a GCP environment. GDP, GLP and ICH E6 standards are a strong asset1+ year of experience as a Lead Auditor, or 3+ years as support on an auditing team Required2+ year of experience in clinical monitoringExcellent working knowledge of Good Clinical Practices and regulatory systems [ISO, FDA, ICH], standards and compliance/auditing techniquesAdditional InformationWe 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 programWork-Life Balance: Paid-time off and family leaveSGS 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.