Onsite Quality & Regulatory Specialist – Lab

Donor Services Laboratory; Las Vegas (NV); On-site; USD 70,000 - 80,000; Full time

Job summary

Donor Services Laboratory in Las Vegas seeks a Quality/Regulatory Specialist to support QA and regulatory compliance at the Las Vegas location. This role ensures adherence to FDA 21 CFR Part 1271, CLIA, CAP, state requirements, and GDP, while supporting audits, documentation, and continuous improvement.

The position focuses on maintaining quality systems, facilitating inspections, and collaborating with laboratory staff to ensure accurate, timely regulatory compliance in a fully onsite lab

Qualifications

• Bachelor’s degree in life sciences, medical technology, or a related field.
• 2–4 years of experience in a regulated clinical, tissue banking, diagnostic laboratory, or similar environment.
• Familiarity with FDA HCT/P regulations, including 21 CFR Part 1271, and CLIA requirements.
• Strong attention to detail and organizational skills.
• Proficiency with Microsoft Office.

Responsibilities

• Maintain and monitor quality systems to support compliance with FDA 21 CFR Part 1271, CLIA, CAP, and state requirements.
• Write, review, and approve controlled documents, including SOPs, forms, and validation protocols.
• Conduct internal audits and support external audits and regulatory inspections.
• Support nonconformance investigations, root cause analysis, and CAPA activities.
• Monitor and document quality metrics, including turnaround times, error rates, and QC failures.
• Maintain laboratory records and logs in accordance with GDP.

Skills

Attention to detail

Organizational skills

Written and verbal communication

Regulatory compliance awareness

Education

Bachelor's degree in life sciences or related field

Tools

MasterControl

Veeva

LabWare

Job description

Donor Services Laboratory in Las Vegas seeks a Quality/Regulatory Specialist to support QA and regulatory compliance at the Las Vegas location. This role ensures adherence to FDA 21 CFR Part 1271, CLIA, CAP, state requirements, and GDP, while supporting audits, documentation, and continuous improvement.

The position focuses on maintaining quality systems, facilitating inspections, and collaborating with laboratory staff to ensure accurate, timely regulatory compliance in a fully onsite lab