Research Associate

Pacer Group; Martinez (CA); On-site; USD 69,000 - 74,000; Full time

Job summary

Pacer Group in Pacheco, CA seeks a Research Associate for 7 months to conduct laboratory testing for IVD product development and remediation. You will perform IHC, ISH, FISH techniques, and document results in line with regulatory requirements.

The ideal candidate has 2–4 years of regulated lab experience, strong data interpretation skills, and familiarity with GMP/QMS SOPs. This full-time contract role offers hands-on scientific exploration and cross-functional collaboration.

Qualifications

• Bachelor's degree in biology or life sciences.
• 2–4 years in IVD/Medical devices in regulated setting.
• 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/FISH preferred.
• Strong analytical, troubleshooting, and data interpretation skills.
• Experience working within a Quality Management System (QMS) and following SOPs.

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.

Skills

IHC

Data analysis

GMP knowledge

Technical documentation

Education

Bachelor's degree in Biology or related Life Science

Tools

ISH

FISH

Assay development

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