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Microbiologist
Pacheco, CA

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Pacer Staffing

Research Associate Representative

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Job Description

Research Associate Representative (Pacheco, CA, 94553) | 10/08/26

Job Description Job Title:

Research Associate Representative

Location:

Pacheco, CA

Duration:

7 Months

Schedule:

Full-Time Contract Position Summary The Research Associate Representative will support laboratory testing, product development, verification and validation, remediation, and technical documentation activities for IVD products. The role requires hands-on experience with IHC and familiarity with regulated laboratory environments, quality systems, and applicable regulatory requirements. Key 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 in accordance with 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 activities.

Maintain accurate laboratory records in accordance with SOPs, GMP, GDP, and Quality Management System (QMS) requirements.

Collaborate with R D, Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing teams. Required Qualifications Bachelor's degree in Biology, Molecular Biology, Biochemistry, Biotechnology, Biomedical Sciences, or a related Life Science discipline.

2-4 years of laboratory experience in IVD, medical devices, diagnostics, biotechnology, or another 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 Immunohistochemistry (IHC).

Experience with ISH and FISH is highly preferred.

Strong analytical, troubleshooting, and data interpretation skills.

Experience working within a QMS and following SOPs.

Excellent communication, documentation, and organizational skills.