GCP​/GLP Auditor

Details for the position are as follows:

• Work Location:
  
  Rahway, NJ – Hybrid
• Hybrid schedule: 3 days onsite — Tuesday and Wednesday are core in‑office days, with the option to work onsite either Monday or Thursday for the third day.
• 22-month contract to start with the possibility of extension or conversion depending on performance and business needs
• Rate: $40-45 an hour

• The Quality Assurance (QA) Specialist provides independent oversight to the Global Research & Development Department of Intervet Inc. d/b/a Client Animal Health (MAH). This role fulfills the responsibilities of the Quality Assurance Unit (QAU) in accordance with VICH GL9 Good Clinical Practice (GCP), FDA 21 CFR Part 58.35, and EPA 40 CFR Part 160.35 Good Laboratory Practice (GLP) regulations.
• The primary objective of this position is to ensure that planned, systematic processes are in place and effectively executed so that studies and associated data are collected, documented, and reported in compliance with applicable regulations, guidance documents, study protocols, standard operating procedures (SOPs), and industry standards.
• Plan and conduct study audits, internal and external facility inspections, and data/report audits to ensure compliance with SOPs, regulatory requirements, and applicable guidelines.
• Review animal health bioanalytical studies conducted in‑house, including auditing GLP data within Analyst and Watson LIMS systems.
• Apply working knowledge of FDA Guidance for Industry – Bioanalytical Method Validation (LC/MS-MS preferred).
• Review protocols and protocol amendments for regulatory compliance, internal consistency, and alignment with SOPs.
• Perform internal audits of MAH research facilities.
• Conduct audits of contract research organizations (CROs) supporting GCP and GLP studies.
• Issue audit reports to MAH management and contractors and ensure timely resolution of observations.

• Bachelor’s degree with 5 years related experience, with at least 2 years auditing experience in the regulatory compliance environment.
• Must have GCP or GLP auditing experience
• Knowledge of VICH GCP Guidelines, FDA, EPA and OECD GLPs, or animal health.

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