Laboratory Quality & Compliance Specialist

ASRT, Inc.; Atlanta (GA); On-site; USD 85,000 - 110,000; Full time

Job summary

ASRT, Inc. provides scientific, information management, management consulting, bioinformatics, and administrative program support to CDC and other clients.

The Laboratory Quality Specialist will support MVPDB at the CDC in Atlanta, focusing on developing, implementing, and maintaining the Branch Quality Management System. You will work with laboratory staff to ensure quality system requirements are met, perform internal audits, analyze data, prepare SOPs and training materials, and manage

Qualifications

• Bachelor's or master's degree in microbiology, biology, chemistry, or basic medical science.
• Minimum of 4 years experience specializing in quality management within a regulated scientific environment.
• Experience adhering to CLSI, ISO, CLIA, FDA guidelines.
• Excellent oral and written communication skills in English.

Responsibilities

• Maintain the Branch Quality Management System in line with CLIA, FDA and ISO guidelines.
• Provide direct lab support for quality system activities and records.
• Coordinate equipment maintenance and calibration with vendors.
• Assist laboratories with documentation and investigation of nonconformances.
• Monitor competency assessments and proficiency testing.
• Assist in internal quality audits and data collation for reviews.
• Develop and update SOPs, training materials, and reports.

Skills

Communication

CAPA & audits

Regulatory knowledge

Documentation & record-keeping

Education

Bachelor's or Master's in microbiology/biology/chemistry/basic medical science

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

ASRT, Inc. provides scientific, information management, management consulting, bioinformatics, and administrative program support to CDC and other clients.

The Laboratory Quality Specialist will support MVPDB at the CDC in Atlanta, focusing on developing, implementing, and maintaining the Branch Quality Management System. You will work with laboratory staff to ensure quality system requirements are met, perform internal audits, analyze data, prepare SOPs and training materials, and manage