Laboratory Quality Specialist @ ASRT, Inc.
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Laboratory Quality Specialist
ASRT, Inc. is seeking a Laboratory Quality Specialist to support the Respiratory Diseases Branch at the CDC in Atlanta, GA. The role will be responsible for maintaining quality management systems, improving lab safety and quality, and ensuring adherence to regulatory requirements.
Scope of Work
The Laboratory Quality Specialist provides scientific and laboratory support aimed at developing, implementing, and maintaining the Branch Quality Management System in accordance with CLIA, FDA, and ISO standards.
Major Duties and Responsibilities
- Participate in maintaining the Branch Quality Management System and ensure compliance with regulatory guidelines.
- Assist in risk assessments for new and current laboratory procedures to improve safety and quality.
- Attend meetings to strategize lab safety improvements and communicate protocol changes.
- Update safety signage, emergency contacts, and evacuation routes as needed.
- Serve as a point of contact for biosafety cabinet maintenance and scheduling annual checks.
- Record and address violations during inspection walk-throughs.
- Provide safety training for new and returning personnel and support public health emergency tasks when necessary.
- Monitor equipment calibration, preventive maintenance, and coordinate with vendors.
- Maintain records in alignment with quality standards and assist with nonconformance investigations.
- Monitor competency assessments and proficiency testing, ensuring overall compliance with quality system requirements.
Requirements
Education and Experience: Bachelor’s or Master's degree in microbiology, biology, chemistry, or basic medical science with a minimum of 2 years experience in quality management within a regulated scientific environment.
Required Skills: Familiarity with Quality Management Plan guidelines (CLSI, ISO, CLIA, FDA), effective communication skills, and knowledge of CAPA, audit, and complaint systems.
Desirable: Strong oral and written communication skills and comfort in a fast-paced, interdisciplinary team environment.
How to Apply
Apply through the ASRT Career page by clicking the "Apply" button or using the provided link if viewing from another site.
Key skills/competency
- Quality Management
- Risk Assessment
- CLIA
- FDA
- ISO
- Documentation
- Calibration
- Preventive Maintenance
- Safety Protocols
- Biosafety
How to Get Hired at ASRT, Inc.
🎯 Tips for Getting Hired
- Customize your resume: Highlight quality management experience.
- Research ASRT, Inc.: Understand company operations and clients.
- Emphasize regulatory knowledge: Include CLIA, FDA, ISO expertise.
- Prepare for technical questions: Review lab safety and calibration protocols.