Develop and maintain technical documentation including test reports, specifications, design documentation, and scientific evidence files. Bachelor's degree in biology, Molecular Biology, Biochemistry, Biotechnology, Biomedical Sciences, or related Life Science discipline.
Numbers & Facts
Location
Pacheco, CA
Salary
$50–$54
Description
Job Title: Research Associate
Location: Pacheco, CA94553
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