SGS: Quality Assurance Specialist II - GCP — Union, NJ, United States

About SGS

SGS provides testing, inspection and certification services. Its employer descriptions connect this work with quality, compliance and sustainability, using laboratory and other business facilities to deliver services. These activities address related but distinct needs: examining products or materials, assessing conditions against requirements, and establishing conformity with an applicable framework. The business provides organisations with evidence and assessments relevant to their operations, supported by scientific, technical and administrative work around the services delivered.

The position and its setting

SGS lists Quality Assurance Specialist II - GCP in Union, NJ, United States, under reference REF87471R. The details below separate the work described by the employer from essential conditions, preferred experience and practical preparation advice.

• Department: Laboratory & Testing
• Employment type: Full-time
• Employer listing date: 23 October 2026
• Contract Type: Standard
• Legal Entity: US_SGS North America Inc.
• Brands: SGS

Responsibilities and work described

• 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
• Quality / delivery: 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
• Quality / delivery: 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

Essential requirements and candidate background

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

Location, schedule and contract conditions

For this overseas or regional listing, confirm work authorisation and any location restrictions with the employer. The location does not establish visa sponsorship or permission to work remotely from India.

• Work arrangement: On-site
• Advertised location: Union, NJ, United States

Benefits mentioned by the employer

• We 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 program
• Work-Life Balance: Paid-time off and family leave
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations
• The requirements listed above are representative of the knowledge, skills, and/or abilities required
• This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job
• Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time
• 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
• Receive a call back

Conditions requiring the complete notice

Some passages contain complex or combined conditions that have not been reduced to short eligibility statements here. Read the complete linked notice for those passages, including any alternatives, exceptions or restrictions. The concise facts above should not be treated as the full wording of every condition.

Pay and application dates

A verified salary figure is not established in this article. An online estimate for another Quality Assurance Specialist II - GCP vacancy is not an offer for reference REF87471R; use the employer’s own pay disclosure and recruitment communication.

A closing date is not confirmed in this article. Check the current employer page before submitting: an undated posting can change or be withdrawn.

How to apply to SGS

Applications follow the official employer page linked below.

Open the official SGS posting below and match the title and reference REF87471R.

Compare your qualifications and experience with the essential conditions for the Union, NJ, United States position, then read the preferred criteria separately.

Prepare an accurate CV and the supporting items requested in that employer’s application. Provide only information and documents you are authorised to share.

Use the employer’s application option, complete the required fields and review the submission. Retain the acknowledgement when one is provided. Job Alerts World does not receive the application.

Practical preparation: quality assurance

For quality assurance, explain the process, controls and records you worked with. A useful example shows how an issue was prevented, investigated or corrected and how the change was checked.

Relevant skills

• GCP / clinical practice
• ISO
• quality assurance
• clinical trials
• audit
• compliance
• training
• GLP
• microbiology
• chemistry