System One

Job Title: QA CSV Auditor

Location: Nutley, NJ (Hybrid)

Hours/Schedule: M-F, 8-5

Type: Contract

Overview:

We are seeking a QA CSV Auditor with experience in Clinical Validation, Computerized System Validation (CSV), and Good Clinical Practice (GCP). This hybrid role requires a strong understanding of clinical operations and regulatory requirements, along with the ability to create and review validation deliverables and communicate their significance to diverse stakeholders. Candidates must be local to the Nutley area and available to work onsite 2–3 days per week.

Responsibilities:

• Review and contribute to validation documentation and deliverables.
• Serve as a QA approver for internal validation efforts.
• Support internal and external audits, including vendor and computerized system audits.
• Evaluate CAPAs and verify CAPA implementation related to audits.
• Act as a liaison to business stakeholders, providing guidance on software validation practices.
• Participate in inspection readiness activities and support health authority audits.
• Collaborate with the clinical QA systems lead on validation and quality initiatives.

Qualifications:

• Bachelor’s degree in IT, Data Sciences, or a related field.
• 3–5 years of experience in the pharmaceutical industry or a similar regulated environment.
• 1–3 years of experience in CSV/vendor auditing.
• Familiarity with software development methodologies including Agile and Waterfall.
• Working knowledge of software validation regulations and GCP/GMP requirements.
• Ability to travel as needed.

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.