We are looking for a full-time, temporary Quality Assurance Coordinator to join our Quality team for a period of three to four months in its mission to ensure our organization builds our platform and flagship assay and operates in alignment with FDA regulations and with a focus on quality and safety. You will support critical functions within quality including document management; record handling and retention, change controls, CAPAs, nonconformance and training records facilitation. This role is for you if you’re organized and love the details.

How You Will Contribute

• Develop a plan to migrate data and files from our SharePoint-based QMS to an eQMS
• Circulate Change Request records and publish new and revised documentation.
• Facilitate training record circulation, and update training matrix
• Monitor and publish dashboard metrics for Quality Objectives weekly - including training compliance, internal audit execution, approved vendor list updates, NCs, CAPAs and other quality objectives as identified
• Publish weekly change request metrics, which include newly executed change requests, listings of updated document changes and new initiations
• File any paper documentation in an orderly and organized fashion
• Assist in organizing and archiving digital records for quality, clinical and regulatory drives
• Assist in facilitating various submission documentation as needed, including file review, basic format editing, and packaging of files as needed

We'd Love to Hear from You if You

• Are exceptionally detail-oriented and organized with an affinity for efficiency
• Communicate clearly and succinctly in both written and oral formats, including structured, technical writing
• Plan and execute projects in an efficient and timely way ensuring alignment from relevant team members and to organizational goals
• Collaborate well across scientific and engineering disciplines
• Resourcefully navigate digital document storage systems and other software-related tools

Desired Education & Experience

• B.S. in a technical field OR 5-10 years’ work experience from Quality Assurance functions within a manufacturing or lab environment including working within GDP, GMP, or GLP environments
• Experience working with SharePoint, eQMS, and/or ERP systems

This role is full-time, hourly, and onsite in Austin, Texas. This temporary position has the possibility of extension and conversion.