Quality Assurance Specialist

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Uphold the highest levels of patient safety and data integrity at clinical research sites through consistent quality assurance evaluations, site quality assistance, and compliance with Standard Operating Procedures.

• Perform thorough reviews of study-specific regulatory binders and clinical documents to ensure they are accurately filled out and maintained according to GCP standards.

• Implement the annual corporate audit plan, systematically monitoring quality assurance audits, overseeing associated activities, and preparing comprehensive outcome reports for management.

• Collaborate closely with research staff and Principal Investigators (PIs) to address identified compliance issues, developing, tracking, and overseeing Corrective and Preventative Action (CAPA) plans.

• Organize and deliver hands-on operational support for on-site audits and inspections conducted by external providers, sponsors, and regulatory bodies.

• Offer ongoing administrative assistance to the Quality Department by managing internal quality systems, compliance trackers, and operational programs.

• Engage in the routine review, drafting, and upkeep of quality assurance Standard Operating Procedures (SOPs) to ensure alignment with changing regulations.

• Serve as an internal quality resource, providing continuous guidance and best-practice recommendations to site personnel and clinical project teams.

• Stay informed about evolving GxP guidelines, demonstrating critical thinking, a willingness to learn, and a commitment to ensuring compliance. Be knowledgeable in interpreting regulatory guidelines such as 21 CFR Part 11/Part 312 and ICH GCP E6 (R3).

• Foster a culture of inspection readiness and ongoing improvement. Adapt to working with risk-based audit agendas and shifting priorities.

• Develop and deliver training on Quality and Improvement initiatives.

• Assist in the completion of RFP/RFI (Request for proposals/information).

• Exhibit a willingness to learn and engage with digital technologies.

• Provide quality support and consultation for AI projects.

• Aid in other activities concerning the management of QMS and data accuracy.

• Address GxP and non-GxP quality issues and/or projects requiring quality consultation and support.

⛳️ Requirements

• Bachelor’s degree

• 2 years of experience in Quality Assurance

• 4 years of experience in Clinical Research with a focus on compliance or a GCP-relevant role

• Proficiency in Portuguese and English; Spanish is a plus.

🏝️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays

• Medical, dental, and vision insurance plan options