What are the responsibilities and job description for the Quality Assurance Specialist – Global R&D QA position at Astrix?
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**
Salary : $55 - $60
