Quality Assurance Specialist II - GCP

About the Position

Quality Assurance Specialist II - GCP

We are seeking a dedicated Quality Assurance Specialist II to join our Global Compliance Program (GCP) team. This role is pivotal in ensuring compliance with quality management systems and regulatory standards in clinical studies.

Responsibilities

• 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.
• 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 participate in clinical study monitoring at SGS Union site along with active participation during audits that are led internally or by sponsors, or accreditation bodies.
• Conduct 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.
• Create cross-training course list for North America QA to ensure qualified back-up QA support.

Requirements

• Bachelor’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 Professional and 2+ years of experience in a Quality Assurance or Operational Leadership role.
• Must have experience working in a GCP environment. GDP, GLP and ICH E6 standards are a strong asset.
• 1+ year of experience as a Lead Auditor, or 3+ years as support on an auditing team.
• 2+ year of experience in clinical monitoring.
• Excellent working knowledge of Good Clinical Practices and regulatory systems [ISO, FDA, ICH], standards and compliance/auditing techniques.

We Offer

• 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 program.
  • Work-Life Balance: Paid-time off and family leave.

About the Company

We 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 Location

• Country: United States

Compensation

• Salary: USD 65,000 - USD 80,000 per year

Employment Type

• Type: Full-time

Contact

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.