At Pattern Bioscience, we're tackling antibiotic resistance, one of the biggest public health challenges of our time. We use machine learning and microfluidics to quickly recognize the bacteria causing an infection and to predict which drugs will cure the infection.
We are looking for a full-time, temporary Quality Assurance Document 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.
To fulfill our mission and build world-changing technology, we've put together a diverse, multi-disciplinary top-notch team, a culture of innovation, learning, adaptability, and excellence and environment where people love coming to work.
We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, neurodiversity, status as a qualified individual with disability, protected veteran status, hair texture or protective hairstyle, or any other characteristic protected by law.