Lab QA Associate - Quality & Compliance

Onterris; Richmond (VA); On-site; USD 27,552 - 31,684; Full time

Job summary

Onterris is seeking a QA Associate to support multiple projects within a controlled lab environment. You will collaborate with multidisciplinary teams and regulatory agencies, ensuring data integrity and adherence to GDP and ISO 17025 standards.

You will perform verifications, support CAPA/RCA processes, draft SOPs, and prepare training materials while maintaining training records. This role emphasizes accuracy, communication and continuous improvement in a fast-paced setting.

Qualifications

• Bachelor’s degree or equivalent in a scientific field.
• 1+ year in a lab or QA role.
• Strong scientific terminology and lab safety.
• Understanding physical/chemical principles behind methods.
• Clear written and verbal communication.
• Ability to collaborate and document data.
• Good organization and time management.
• Proficiency in Microsoft Office.
• Familiarity with ISO 17025, GDP, CAPA, RCA a plus.
• Experience with LIMS.
• Data visualization for reports.
• Conflict resolution and clear communication.
• multitask and prioritize effectively.
• Team player, independent yet collaborative.

Responsibilities

• Track verifications of lab equipment per SOP.
• Review logs/data for GDP compliance.
• Initiate non-conformances for corrective actions.
• Create control charts and audit lab data.
• Track CAPA and perform RCA.
• Conduct internal audits of lab processes.
• Prepare audit checklists and follow-up on findings.
• Communicate updates to internal/external clients.
• Draft and revise SOPs and forms.
• Review PT data and results.
• Troubleshoot and solve problems.
• Deliver in-lab GDP, ethics, safety training.
• Maintain training records and competency.
• Archive documents per SOPs.
• Ensure ISO/TNI compliance in data review.
• Support external audits.
• Communicate timely updates.
• Adhere to PPE and waste handling.

Skills

Laboratory procedures

Data interpretation

Analytical thinking

Documentation

Communication

Education

Bachelor’s degree in a scientific field

Tools

LIMS

Microsoft Office

Data visualization tools

Job description

Onterris is seeking a QA Associate to support multiple projects within a controlled lab environment. You will collaborate with multidisciplinary teams and regulatory agencies, ensuring data integrity and adherence to GDP and ISO 17025 standards.

You will perform verifications, support CAPA/RCA processes, draft SOPs, and prepare training materials while maintaining training records. This role emphasizes accuracy, communication and continuous improvement in a fast-paced setting.