Quality Assurance Specialist – Global R&D QA

Please note that we are unable to provide sponsorship, accommodate C2C arrangements, or offer relocation assistance for this opportunity. Join a leading pharmaceutical company and play a crucial role in ensuring regulatory compliance within Global Research and Development. We are seeking a Quality Assurance Specialist with expertise in GLP auditing and R&D quality assurance to support high-quality study submissions and regulatory compliance efforts. Location: Rahway, NJ (Hybrid: 3 days onsite – Tuesday & Wednesday core days, plus choice of Monday or Thursday) Schedule: Monday – Friday, 8 AM – 5 PM Pay: $60/hr Key Responsibilities: • Provide Quality Assurance oversight for GLP and GCP studies in animal health research. • Ensure compliance with FDA 21 CFR Part 58 Good Laboratory Practice Regulations (GLPs) and VICH GL9 Good Clinical Practice (GCP) guidance. • Review protocols, amendments, data, and reports for GCP and GLP studies, including in-house bioanalytical studies. • Issue and track audit reports, ensuring appropriate responses and corrective actions. • Conduct internal facility inspections of research sites and issue reports to management. • Ensure that study data is collected, documented, and reported in compliance with regulatory requirements, study protocols, SOPs, and industry standards. Qualifications & Skills: ? Education: Bachelor’s degree with at least 2 years of GLP auditing experience in an R&D regulatory compliance environment or 3 years of related experience. ? Experience: • GLP environment experience required. • QA R&D experience or GLP data review required. • Animal Health Clinical Auditing experience is a plus. • ? Technical Skills: • Proficiency in MS Office Suite and My Learning Experience. • Familiarity with GLP data auditing in Analyst and Watson LIMS is a plus. • ? Soft Skills: • Strong communication, organization, and writing skills. • Ability to perform effectively in a multi-tasking environment. What We’re NOT Looking For: ? GMP auditing experience ? IT QA or IT quality system experience Why Join Us? ? Competitive Pay: $60/hr ? Hybrid Work Model: Flexible structure with 3 onsite days per week ? Impactful Work: Support cutting-edge research and ensure compliance with global regulatory standards If you're a detail-oriented Quality Assurance Specialist with a background in GLP auditing and R&D compliance, we’d love to hear from you! Apply today to be part of an industry-leading team. • *This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you** Apply Job!