Quality Control Scientist

Invivoscribe; San Diego (CA); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Competitive compensation

Performance incentives

Collaborative culture

Impact in precision medicine

Job summary

Invivoscribe in San Diego is seeking a Quality Control Scientist I to apply scientific principles to QC data analysis, investigations, and continuous improvement within a GMP-regulated environment.

The role requires a MS degree and 4+ years in biotechnology or related QC fields, with experience in molecular biology and QC testing methodologies. The company emphasizes ISO 13485 design control and global impact in precision diagnostics.

Qualifications

• Must have MS degree in a scientific discipline with 4+ years in biotechnology, chemistry, or pharmaceutical QC (GMP).
• Substantial experience with development, validation, optimization, troubleshooting, or implementation of lab test methods or processes.
• Experience with molecular biology and/or molecular diagnostic testing in GMP environments.
• Proficient with QC data analysis, statistics, and data interpretation.

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.
• Creates, implements, maintains and improves SOPs, acceptance criteria, and other QC documents.
• Ensures QC procedures reflect current testing procedures, validated methods, product requirements, and 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, and opportunities for improvement, with corrective actions.
• Develops and maintains QC metrics, reports, and visualizations for technical reviews.
• Identifies opportunities to improve QC efficiency, reliability, throughput, and data integrity through automation and technology.
• Leads or provides technical assistance, including FMEA, for investigations involving quality events and related studies.

Skills

Molecular biology

Statistical QC

GMP experience

Technical investigations

Automation familiarity

Education

M.S. degree in a scientific discipline

Tools

3500xl Dx

ABI 7500 Dx

MiSeq Dx

BioTek plate fluorometer

QiaCube

2100 Bioanalyzer

TapeStation

LabChip Gx

NanoDrop

iBright

Job description

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
• 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.