QC Scientist I, Molecular Diagnostics (GMP)

Invivoscribe, Inc.; San Diego (CA); Hybrid; USD 85,000 - 95,000; Full time

Job summary

Invivoscribe, Inc. in San Diego, CA is seeking a Quality Control Scientist I to join our QC team. This full-time role focuses on developing and validating QC methods, performing data analysis, and supporting product releases and investigations in a GMP environment.

You will work with listed instruments, contribute to SOPs, CAPAs, and continuous improvement, and communicate findings to cross-functional teams. A MS degree and 4+ years in biotech QC are required; advanced degree preferred.

Qualifications

• MS degree in a scientific discipline; typically 4+ years in biotech QC lab within GMP setting.
• Experience with development, validation, optimization, troubleshooting, or implementation of lab test methods or processes.
• Strong background in molecular biology or molecular diagnostics in GMP environments.
• Hands-on proficiency with listed analytical instruments and quality systems.

Responsibilities

• Develop, improve and validate QC testing methods and processes.
• Generate QC validation protocols and reports.
• Support transfer and implementation of new or modified test methods into routine QC operations.
• Create, maintain and improve SOPs, acceptance criteria, and QC documents.
• Analyze QC data for trends and recommend corrective or preventive actions.
• Develop QC metrics, reports, and visualizations for technical review.

Skills

Statistical quality control

Laboratory automation

Analytical problem solving

Education

MS degree in scientific discipline

Tools

3500xl Dx

ABI 7500 Dx

MiSeq Dx

BioTek plate fluorometer

QiaCube

2100 Bioanalyzer

TapeStation

LabChip Gx

NanoDrop

iBright

Job description

Invivoscribe, Inc. in San Diego, CA is seeking a Quality Control Scientist I to join our QC team. This full-time role focuses on developing and validating QC methods, performing data analysis, and supporting product releases and investigations in a GMP environment.

You will work with listed instruments, contribute to SOPs, CAPAs, and continuous improvement, and communicate findings to cross-functional teams. A MS degree and 4+ years in biotech QC are required; advanced degree preferred.