Job Url: https://www.remoterocketship.com/company/criterionedge/jobs/ai-powered-quality-control-specialist-united-states-remote Job Description: Criterion Edge Website LinkedIn All Job Openings Criterion Edge is a distinguished global provider in the MedTech industry, dedicated to advancing compliance and enhancing market success for Medical Device, Pharma, and In Vitro Diagnostics companies through expert regulatory, scientific, and clinical writing services. With a team of seasoned regulatory writers and medical librarians, Criterion Edge collaborates with its clients to produce high-quality, compliant documentation that meets global regulatory standards and accelerates approval timelines. Medical Writing • Regulatory Writing • Medical Devices • Pharmaceutical • Clinical Submissions 11 - 50 employees ⚕️ Healthcare Insurance 💊 Pharmaceuticals 🧬 Biotechnology AI-Powered Quality Control Specialist 5 days ago 🇺🇸 United States – Remote ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🤖 Artificial Intelligence Apply Now Receive Emails with Similar Jobs Report problem 📋 Description • We are seeking a detail-oriented and tech-savvy Quality Control (QC) Specialist to join our Regulatory Medical Writing team. • This role combines traditional QC expertise with the innovative application of artificial intelligence to ensure the accuracy, consistency, and compliance of regulatory documents. • Conduct QC reviews of moderately to highly complex clinical and regulatory documents (e.g., Clinical Evaluation Reports [CER], Clinical Evaluation Plans [CEP], Clinical Study Reports, Protocols, Investigator's Brochure, Module 2 summaries) using both manual and AI-assisted methods. • Validate the accuracy of data, interpretation, and references by comparing against source documents (e.g., statistical outputs, protocols, SAPs). • Use AI tools to flag inconsistencies in grammar, formatting, data presentation, and adherence to style guides. • Ensure compliance with internal templates, regulatory guidelines (ICH, FDA), and company SOPs. • Collaborate with Medical Writers to improve document clarity, accuracy, and readiness for submission. • Provide guidance and troubleshooting on AI-supported QC platforms and workflows. • Maintain QC documentation within electronic document management systems (e.g., SharePoint). • Participate in process improvement initiatives, including the development of AI workflows for QC activities. 🎯 Requirements • Bachelor’s degree or higher in a life science discipline • 3–5 years of experience in regulatory or clinical medical writing, with at least 2 years in QC or document review roles • Familiarity with clinical development processes and regulatory documentation standards • Experience using or deploying AI/NLP tools in a document review or QC setting (e.g., tools that extract, compare, or validate data/text) • Advanced proficiency in Microsoft Word and Excel, including template management and formatting controls • Familiarity with citation managers (e.g., EndNote) and regulatory document standards (e.g., AMA Style, GCP) • Detail-oriented with excellent organizational and communication skills • Ability to independently manage multiple QC assignments under tight timelines Apply Now