GCP​/GLP QA Auditor - Animal Health Products

Overview

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Source Inc.

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Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision—Right Talent. Right Time. Right Place. Right Price.

Title: GCP/GLPQA Auditor - Animal Health Products

Duration: 09 Months Contract

Location: Rahway, NJ (Hybrid)

Shift: Tuesday and Wednesday onsite (core days) + choice of Monday or Thursday for third onsite day

This position will provide Quality Assurance oversight to Client Global Research and Development Department. It will satisfy the requirements for a Quality Assurance Unit (QAU) according to the Good Clinical Practice VICH GL9 Guidance Document, FDA 21 CFR Part 58.35 and EPA 40 CFR Part 160.35 Good Laboratory Practices.

The primary focus of this position is to ensure that planned and systematic processes are established so that studies and data are collected, documented, and reported in compliance with applicable regulations, guidance documents, study protocols, SOPs, and industry standards. This role may also develop and provide training on regulatory compliance issues and assist management during government or corporate inspections.

• Plan and conduct study, internal, and external facility inspections, as well as data and report audits to ensure compliance with SOPs, government regulations, and guidelines
• Issue audit reports to study monitors, study directors, investigators, and management as appropriate
• Track audit reports and review responses to ensure appropriate corrective actions and documentation
• Review animal health bioanalytical studies conducted in-house
• Audit GLP data in Analyst and Watson LIMS systems
• Apply working knowledge of FDA Guidance for Industry Bioanalytical Method Validation (LC/MS-MS preferred)
• Perform facility inspections and audits of contract research organizations supporting GCP and GLP studies
• Issue audit reports to Client management and contractors and ensure resolution of observations
• Assist Global R&D QA management during FDA, EPA, and Corporate inspections
• Provide GCP workload status reports and deliver GCP/GLP training to personnel as appropriate
• Review, revise, and develop SOPs governing the Global R&D QA function
• Conduct internal facility audits of research facilities
• Review protocols and amendments for compliance and internal consistency
• Conduct GLP training for Global R&D departments

• Bachelor's degree with 5 years related experience, including at least 2 years auditing experience in a regulatory compliance environment
• Strong communication, organization, and technical writing skills
• Knowledge of VICH GCP Guidelines, FDA, EPA, and OECD GLPs
• Ability to perform effectively in a multi-task environment
• Ability to facilitate and/or lead various meeting formats
• Working knowledge of bioanalytical method validation preferred

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• America s Most Honored Businesses (Top 10%)
• Fastest-Growing Staffing Firm by Staffing Industry Analysts
• INC 5000 List for Eight Consecutive Years
• Top 100 by Dallas Business Journal
• Spirit of Alliance Award by Agile1

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