Clinical QA Specialist II
Skills
- Working knowledge of GLP and (Veterinary) GCP standards and applicable regulations
- Proficiency with electronic data capture (EDC) systems and IWRS/study drug inventory systems
- Experience performing audits, root cause analysis, and CAPA development
- Ability to design and run user acceptance testing (UAT) for study-specific EDC builds
- Strong written and verbal communication for cross-functional collaboration
- Excellent organization, follow-up, and attention to detail
- Analytical problem solving within regulatory guidance
- Ability to travel up to 40% regionally and nationally
Responsibilities
- Implement and participate in a rigorous quality control program for clinical and pre-clinical studies
- Conduct site visits with CRAs to verify procedural quality and data collection at source
- Maintain and organize QMS documentation including SOPs, CAPAs, and training records
- Provide GCP guidance and support to clinical teams on day-to-day trial activities
- Identify data discrepancies and coordinate remediation or training with ops teams
- Standardize data collection methods and quality processes from initiation to closeout
- Support internal and external audits, vendor and site audits; track findings and CAPAs
- Perform user acceptance testing (UAT) of EDC builds and manage IWRS/drug inventory oversight
- Develop risk-based audit plans and participate in risk identification and mitigation
- Maintain quality metrics dashboards and assist with management reporting
Education
- Bachelor's degree in animal science, biology, veterinary or related life sciences or equivalent experience
- Equivalent experience may include roles such as veterinary technician, clinical assistant, or study coordinator
Benefits
- Full-coverage medical, dental, and vision insurance for employees and dependents
- $1,000 home office equipment stipend
- $1,200/year learning budget
- $250/month wellness stipend
- 4-day weekends (all 3-day weekends turned into 4-day weekends)
- Unlimited vacation and paid holidays
- Paw-ternity leave for new adopted dogs
- Competitive salary and company equity options
Average salary estimate
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