Quality Control Scientist

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.
• 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.