Quality/Regulatory Specialist

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 (DSL) is a highly accredited clinical reference laboratory serving the human transplantation and biomedical industries. With locations in Las Vegas and Tampa, DSL provides donor and clinical testing services with a focus on accuracy, timely results, and regulatory compliance.

Position Overview

Donor Services Laboratory is seeking a Quality/Regulatory Specialist to support quality assurance and regulatory compliance at our Las Vegas location. This position supports compliance with FDA 21 CFR Part 1271, CLIA, CAP, applicable state requirements, and Good Documentation Practices (GDP).

The Quality/Regulatory Specialist works closely with laboratory personnel to maintain quality systems, support audits and inspections, manage documentation, and drive continuous improvement.

This is a fully onsite position in Las Vegas, Nevada.

Salary: $70,000–$80,000 per year

Key Responsibilities

Quality Systems

• Maintain and monitor quality systems to support compliance with FDA 21 CFR Part 1271, CLIA, CAP, and applicable 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.

Laboratory Compliance

• Monitor and document quality metrics, including turnaround times, error rates, and QC failures.
• Maintain laboratory records and logs in accordance with Good Documentation Practices.
• Participate in the review of lot release, testing results, and QA/QC data.

Training and Competency

• Track training records and competency requirements for laboratory personnel.
• Support onboarding and ongoing quality and compliance training.

Regulatory and Accreditation

• Prepare documentation and support inspection activities involving FDA, CLIA, CAP, and state health departments.
• Help ensure laboratory practices remain aligned with applicable regulations and accreditation standards.
• Participate in Quality Management Reviews and process improvement initiatives.
• Identify opportunities to improve compliance, efficiency, and customer service.

Qualifications

Required

• 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.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office.

Preferred

• Experience with quality management systems, document control, and audit support.
• Experience with electronic quality systems such as MasterControl, Veeva, or LabWare.
• Experience in human tissue or blood testing, biobanking, or a related field.
• Knowledge of accreditation requirements such as CAP, AATB, or FACT.
• ASQ certification such as CQA or CQE.
• Fully onsite at our Las Vegas, Nevada location.
• Primarily an office-based role within a laboratory environment.
• Must be able to follow laboratory safety and biosafety requirements when working in or around laboratory areas.
• Occasional weekend or off-hours work may be required to support audits or urgent quality matters.