Quality Assurance Associate
About TrialSpark
TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.
The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. To combat this industry problem, TrialSpark has built a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.
TrialSpark recently raised their Series C, and is putting the capital to work by in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.
About the Position
As a Quality Assurance Coordinator you will be reporting to the Head of Quality Assurance. The Quality Assurance Coordinator will assist the Quality Assurance team in maintenance, organization and tracking of QA files and metrics.
Responsibilities are, but not limited to:
- Assist in QA files including: training, contractor/consultant, inspection, and audit and responses files
- Coordinate and maintain tracking of the audit process, including: assigning audit numbers, tracking audit process timelines, confirmation receipts and completion of CAPAs
- Issue and distribute audit documentation such as audit reports and audit responses
- Prepare information/data for management reporting
- Administration of Learning Management System
- Assist in managing Document Management System /Learning Management System workflows. Support in the development of Quality Assurance dashboards, quality metrics (Key Quality Indicators) , management reports as needed.
- Manage and oversee various QA administrative tasks as needed.
Relevant Experience:
- Prior experience in managing quality systems (controlled documents, training platforms, learners), Document Management Systems
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
