About this role
Invivoscribe is an industry pioneer and global leader in precision oncology diagnostics. For more than 30 years we have driven international standardization of molecular and flow cytometry testing and expanded access to advanced cancer therapies worldwide. Our mission is simple and unwavering: Improving Lives with Precision Diagnostics ®
We are seeking a Quality Control Scientist I. The QC Scientist I serves as a technical subject matter expert related to QC processes and procedures and QC representative for projects, product release, field actions, and post-market activities. This role involves applying scientific principles to quality control statistical data analysis, technical investigations, process improvement, and ongoing QC technical support.
Headquartered in San Diego, with operations across North America, Europe, and Asia, Invivoscribe develops and manufactures a comprehensive portfolio of molecular and flow cytometry assays, reagents, controls, and bioinformatics tools under ISO 13485 design control. Our products and services support more than 700 clinical laboratories in over 160 countries.
Core Responsibilities
- ✓Develops, improves and validates QC testing methods and processes.
- ✓Generates QC validation protocols and reports.
- ✓Supports transfer and implementation of new or modified test methods into routine QC operations.
- ✓Effectively creates, implements, maintains and improves the Standard Operating Procedures (SOPs), acceptance criteria, and other QC related documents.
- ✓Ensures that QC procedures accurately reflect current quality testing procedures, validated methods, product requirements, and applicable quality system requirements.
- ✓Designs, implements, and maintains statistical quality control and post-market surveillance activities.
- ✓Performs analysis and trending of QC data to identify shifts, trends, outliers, recurring issues, and opportunities for improvement, and recommends appropriate corrective, preventive, or improvement actions.
- ✓Develops and maintains QC metrics, reports, and visualizations to support technical review and testing process continuity.
- ✓Identifies opportunities to improve QC efficiency, reliability, consistency, throughput, and data integrity through automation and technology.Leads or provides technical assistance, including FMEA, for investigations involving NCMRs, PDs, CAPAs, product complaints and other quality events, including the designs and executes technical studies.
Core Requirements
- ✓M.S. degree in a scientific discipline and, typically, 4+ years of experience in biotechnology, chemistry, or pharmaceutical QC laboratory to include 4+ years of molecular biology experience in a GMP regulated industry. Equivalent combination of education and experience will be considered. Advanced degree preferred.
- ✓Substantial experience with development, validation, optimization, troubleshooting, or implementation of laboratory test methods or technical processes.
- ✓Sound experience in molecular biology and/or molecular diagnostic testing in a GMP-regulated environment.
- ✓Substantial experimental skills with 3500xl Dx, ABI 7500 Dx, MiSeq Dx, BioTek plate fluorometer, QiaCube, 2100 Bioanalyzer, TapeStation, LabChip Gx, NanoDrop Spectrophotometer, iBright, single and multichannel pipettes.
- ✓High level proficiency in statistical quality control and application of statistical methods to laboratory, manufacturing, or quality data.
- ✓High level proficiency with medical device quality and regulatory requirements including QSR and ISO quality system standards, the IVD Directive and the IVD Regulation.
- ✓High level proficiency of GMP QC environment, including use of SOPs, MBRs, QCACs, QTPs, PSs and Oracle systems.
- ✓Experience with laboratory automation, automated liquid handling, automated data analysis tools, or process automation.
Why Join Us
At Invivoscribe, you will join a mission-driven global organization advancing the future of precision oncology. You will have the opportunity to shape major scientific and commercial partnerships that impact patients around the world. We offer:
- ✓Competitive compensation and performance incentives
- ✓Comprehensive global benefits
- ✓A collaborative, innovation-driven culture
- ✓The opportunity to make a significant global impact in precision medicine
If you are a persistent scientist with an aptitude for complex problem solving and a drive for continuous improvement, we look forward to speaking with you.
Invivoscribe is an Equal Opportunity Employer.