Job Description

Job Title: Research Associate

Location: Pacheco, CA 94553

Duration: 7 months

Shift Timings: Standard Shift

PR: $50 to $54/hr.

Responsibilities

• Plan, perform, document, and evaluate laboratory testing for IVD product development and remediation activities.
• Conduct Immunohistochemistry (IHC), In Situ Hybridization (ISH), Fluorescence in Situ Hybridization (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 Quality Management System requirements.
• Collaborate with R&D, Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing teams.
• This is a full-time- contract opportunity.

The Ideal Candidate will have:

Required Qualifications

• Bachelor's degree in biology, Molecular Biology, Biochemistry, Biotechnology, Biomedical Sciences, or related Life Science discipline.
• 2-4 years of laboratory experience in IVD, Medical Devices, Diagnostics, Biotechnology, or a regulated environment.
• Experience with verification, validation, and experimental study execution.
• Knowledge of EU IVDR (In Vitro Diagnostic Regulation).
• Experience in preparing technical documentation, protocols, reports, and controlled records.
• Hands-on experience with IHC; experience with ISH and FISH is highly preferred.
• Strong analytical, troubleshooting, and data interpretation skills.
• Experience working within a Quality Management System (QMS) and following SOPs.
• Excellent communication, documentation, and organizational skills

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