Quality Control Scientist – Molecular Diagnostics & Data Insight

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 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.