What are the responsibilities and job description for the Quality Specialist - III GLP Pharma position at Collabera?
Responsibilities:
This position provides Quality Assurance oversight Global Research and Development Department. It fulfills Quality Assurance Unit (QAU) requirements under FDA 21 CFR Part 58 GLP Regulations and VICH GL9 GCP Guidelines. The primary responsibility is ensuring study compliance with GLPs, GCPs, regulatory requirements, study protocols, SOPs, and industry standards.
Support the completion of final study reports for GCP and GLP studies submitted to CVM, EPA, and international regulatory agencies.
Conduct protocol, protocol amendment, data, and report reviews for animal health GCP and GLP studies, including bioanalytical studies.
Audit GLP data in Analyst and Watson LIMS systems (preferred but not required).
Issue audit reports to study monitors, study directors, investigators, and study management. Track reports and review responses to ensure corrective actions are documented and implemented.
Assist in internal facility inspections at Animal Health research facilities and issue reports to department management.
Location:
- Hybrid - 3 day onsite in Rahway, NJ
Pay Range:
- $55 - $60 per hour
Education & Experience:
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.
Must-Have Qualifications:
QA R&D experience or experience reviewing GLP data
Experience working in a GLP environment
Animal Health Clinical Auditing experience is a plus
Strong communication, organization, and writing
Ability to multi-task effectively in a fast-paced environment
Software Skill:
Experience with My Learning systems
Work Schedule & Location:
Hybrid role - 3 day onsite per week in Rahway, NJ
Mandatory onsite: Tuesday & Wednesday
Choice of Monday or Thursday as the third onsite
Salary : $50 - $60
