BSL-3 Lab QA & Compliance Specialist

Jobtailor; Atlanta (GA); On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor in Atlanta, Georgia is seeking a seasoned laboratory QA/QC professional to lead the quality assurance program in a CGMP environment. You will review quality data, coordinate accreditation activities, and manage documentation and policy review to ensure regulatory compliance.

The ideal candidate has at least 5 years in QA/QC, experience with CAPA, CLIA, BSL-3 programs, and strong communication skills to collaborate with clients and management on risk, audits, and continuous improvement.

Qualifications

• Minimum 5 years of laboratory QA/QC experience in a cGMP environment.
• Experience with quality management systems, CAPA, LSRB, OLSS, and CLIA compliance.
• Prior experience supporting BSL-3 programs and high containment practices.
• Experience triaging feedback, complaints, and non-conforming events, with documented CAPA activity.
• Ability to obtain Hepatitis B immunization and government clearance; US work authorization required.

Responsibilities

• Assist with development, implementation, and annual assessment of the laboratory QA program.
• Review quality occurrence data and provide reports with monitors and graphical data to management and clients.
• Serve as document control officer for Laboratory Services procedures; ensure annual review and approval of policies.
• Coordinate CDC POC testing program activities, including equipment evaluation and QC monitoring.
• Coordinate accreditation activities to meet governmental standards.
• Manage equipment maintenance, cleaning, and decontamination for repair.
• Maintain and link ELIMS with equipment and rooms.
• Monitor daily temperature using data loggers and thermometers; download deviations.
• Coordinate validation and implementation of new testing and instrumentation.
• Prepare presentations and educate committees and staff; develop strategy and action plans.
• Serve as primary contact with client quality managers.
• Analyze risk management inquiries and client concerns; assist staffing across the service line.

Skills

Quality Assurance

QA/QC Methods

Regulatory Compliance

CAPA

Documentation

Tools

USB EasyLog Software

NCE Database

Data Loggers

Job description

Jobtailor in Atlanta, Georgia is seeking a seasoned laboratory QA/QC professional to lead the quality assurance program in a CGMP environment. You will review quality data, coordinate accreditation activities, and manage documentation and policy review to ensure regulatory compliance.

The ideal candidate has at least 5 years in QA/QC, experience with CAPA, CLIA, BSL-3 programs, and strong communication skills to collaborate with clients and management on risk, audits, and continuous improvement.