Quality Assurance Associate I - Lab Compliance & Data Integrity

Onterris; Orange (CA); On-site; USD 30,000 - 37,000; Full time

Job summary

Onterris is seeking a Quality Assurance Associate I to join our Orange, CA laboratory. You will help maintain systems, processes, and standards that support reliable operations through audits, CAPA tracking, and training support.

Ideal candidates have hands-on lab experience in a TNI-compliant environment, a keen eye for detail, and a commitment to data integrity and continuous improvement. This onsite role emphasizes daily documentation and cross‑functional collaboration.

Qualifications

• Bachelor’s degree or equivalent in a scientific field, or a combination of education, training, and experience.
• 1+ years of relevant experience working in a laboratory or quality assurance role (or equivalent).
• Strong understanding of scientific terminology, analytical laboratory procedures, and lab safety.
• Good written and verbal communication, with sharp editorial and proofreading abilities.
• Ability to collaborate with lab teams to gather, interpret, and document data.

Responsibilities

• Track or perform verifications of laboratory supply equipment to ensure operational reliability per SOP and manufacturer specifications.
• Perform daily/weekly reviews of appropriate logbooks, bench sheets, or data for GDP compliance.
• Initiate and address non-conformances for corrective actions.
• Collect and interpret quality control data, create control charts, and audit sample reports to track lab performance and identify trends.
• Track CAPA and perform or assist with Root Cause Analysis (RCA).
• Conduct routine internal audits of laboratory processes, documentation, and facilities.
• Prepare audit checklists, reports, and follow‑up on findings.
• Accurate and timely communication with internal and external clients.
• Draft, review, and/or revise SOPs, work instructions, forms, or other controlled documents.
• Review laboratory data, workflows, and procedures to ensure accuracy and compliance with TNI 2016, ISO 17025, client requirements, and our robust quality system.
• Support external audits.

Skills

Lab safety

Analytical procedures

Data interpretation

Documentation

MS Office

Education

Bachelor’s degree or equivalent in a scientific field

Tools

LIMS

Data visualization tools

MS Office

Job description

Onterris is seeking a Quality Assurance Associate I to join our Orange, CA laboratory. You will help maintain systems, processes, and standards that support reliable operations through audits, CAPA tracking, and training support.

Ideal candidates have hands-on lab experience in a TNI-compliant environment, a keen eye for detail, and a commitment to data integrity and continuous improvement. This onsite role emphasizes daily documentation and cross‑functional collaboration.