Quality Assurance Specialist II GCP

SGS; Union (NJ); On-site; USD 59,000 - 72,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Tuition reimbursement

Job summary

SGS is seeking a Quality Assurance Specialist II for the Cosmetics and Hygiene division at the Union site in New Jersey. The role focuses on standardizing and improving the quality management system, conducting audits per ISO 19011, and supporting regulatory audits to ensure compliance with GCP, ISO, FDA, ICH standards.

The position involves overseeing clinical studies, monitoring study documentation, and collaborating with cross-functional teams to meet KPIs and timelines while fostering QA

Qualifications

• Bachelor’s degree in Biology, Microbiology, Chemistry, Biochemistry, Business Administration, QA or Regulatory Compliance.
• 3+ years 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 strong 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 QMS requirements to demonstrate SGS’s ability to perform clinical trial studies on human subjects.
• Adhere to the SGS Cosmetics and Hygiene Quality Manual for activities at the Union site and coordinate changes with Operational leaders.
• Participate in clinical study monitoring and internal or sponsor/auditor-led audits.
• Oversee ongoing clinical studies with real-time document reviews and timely escalation of events/non-compliances.
• Ensure study timelines are met by tracking KPIs and collaborating with cross-functional teams.
• Be self-motivated and agile to manage competing priorities with high quality.
• Create cross-training course lists for North America QA for back-up support.

Skills

Quality Assurance

Auditing

Clinical Monitoring

Regulatory Compliance

Education

Bachelor’s degree

Job description

Job Description

The 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.

Qualifications

• 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 strong 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

• Excellent working knowledge of Good Clinical Practices and regulatory systems [ISO, FDA, ICH], standards and compliance/auditing techniques

Additional Information

Our Benefits

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

SGS 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.

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. You will receive a call back. 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.

Compensation

$65,000-$65,000 per year