Quality Control Scientist I

INVIVOSCRIBE INC•San Diego, CA

6d•$85,000 - $95,000

About The Position

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. 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.

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.
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.

Nice To Haves

Advanced degree preferred.

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.