IVD Research Associate — Lab R&D & Quality Specialist

Volt; Martinez (CA); On-site; USD 72,000 - 80,000; Full time

Benefits offered by this job

Health

Dental

Vision

Term life

Short term disability

AD&D

401(k)

Sick time

Other paid leaves

EAP

Job summary

Volt is hiring a Research Associate Representative in Pacheco, CA to plan, perform and document laboratory testing for IVD product development and remediation. You will conduct IHC, ISH, and FISH procedures and execute verification/validation studies per approved protocols.

The role requires a life sciences bachelor's degree and 2–4 years of regulated lab experience, with strong data analysis, documentation, and teamwork across R&D, QA, Regulatory, and Manufacturing.

Qualifications

• Bachelor's degree in a life science discipline.
• 2–4 years of laboratory experience in IVD, medical devices, diagnostics, biotech, or regulated environment.
• Experience with verification, validation, and experimental study execution.
• Knowledge of EU IVDR (In Vitro Diagnostic Regulation).
• Experience preparing technical documentation, protocols, reports, and controlled records.
• Hands-on experience with IHC; ISH and FISH preferred.
• Strong analytical, troubleshooting, and data interpretation skills.
• Experience working within a QMS and following SOPs.
• Excellent communication, documentation, and organizational skills.

Responsibilities

• Plan, perform, document, and evaluate laboratory testing for IVD product development and remediation.
• Conduct IHC, ISH, FISH and related laboratory procedures.
• Execute verification and validation studies according to approved protocols and regulatory requirements.
• Analyze experimental data and prepare technical reports, study summaries, protocols, and conclusions.
• Develop and maintain technical documentation including test reports, specifications, design documentation, and scientific evidence files.
• Support product investigations, nonconformance assessments, complaint investigations, and corrective actions.
• Identify testing and documentation gaps and participate in remediation efforts.
• Maintain accurate laboratory records in accordance with SOPs, GMP, GDP, and QMS requirements.
• Collaborate with R&D, Regulatory Affairs, QA, Clinical, and Manufacturing teams.

Skills

IHC

ISH/FISH

Data analysis

Regulatory/documentation

Communication

Education

Bachelor's degree in Biology, Molecular Biology, Biochemistry, Biotechnology, Biomedical Sciences, or related Life Science discipline

Job description

Volt is hiring a Research Associate Representative in Pacheco, CA to plan, perform and document laboratory testing for IVD product development and remediation. You will conduct IHC, ISH, and FISH procedures and execute verification/validation studies per approved protocols.

The role requires a life sciences bachelor's degree and 2–4 years of regulated lab experience, with strong data analysis, documentation, and teamwork across R&D, QA, Regulatory, and Manufacturing.