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**

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