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: Bachelors 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 Were 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, wed 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 Now
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: Bachelors 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 Were 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, wed 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 Now