Quality Assurance Associate

Metro Manila, Philippines /
Quality & Regulatory – Quality & Regulatory /
Full Time Employee
At InterVenn, we believe no one should ever be blindsided by disease. Our technology enables and empowers the understanding of Glycoproteomics, a new clinical layer of biology beyond the genome, using a simple blood draw. InterVenn’s powerful solutions will broaden humankinds’ perception and interpretation of diseases like cancer. We look forward to having new members join our team who have diverse perspectives and backgrounds, challenge the status quo, and are solution oriented. If this is you, read-on and apply. Together, maybe we can change the world.

RESPONSIBILITIES

    • Manage document control process and act as system administrator for company’s electronic document management system
    • Responsible for providing quality oversight to the change management system for change controls. This includes providing plan creation oversight, verifying the change adheres to internal procedures, regulatory requirements, and ensuring communication and escalation of potential issues of broader impact to the business
    • Maintain and support development and implementation of company policies/procedures and ensure compliance and adherence to regulated QA activities for commercial operations
    • Track and maintain quality metrics and report to management in specified frequency. Reporting to management areas of performance that are not improving with recommendations for next steps
    • Participate in the internal, supplier audit programs and audits by outside agencies
    • Participate in several LDT test development and launch activities
    • Other duties as assigned

QUALIFICATIONS

    • BS in biological sciences, chemistry or analytical chemistry
    • >5 years experience heading quality organizations
    • Extensive experience in document control, change control, and validation of systems
    • Experience in managing and validating electronic document management systems (EDMS) and/or product lifecycle management (PLM) is a must
    • Operated in regulated environments
    • A genuine desire to impact patient lives
Ensuring a diverse and inclusive workplace where we learn from each other is core to InterVenn’s values. We welcome people of different backgrounds, experiences, abilities and perspectives. We are an equal opportunity employer and a fun place to work. Come do the best work of your life here at InterVenn.