ASRT, Inc. · 6 hours ago
Laboratory Quality Specialist
Atlanta, GA
Full-time
Onsite
Mid, Senior Level
4+ years expASRT, Inc. provides scientific and administrative support to the CDC and other clients. The Laboratory Quality Specialist will support the Bacterial Meningitis Laboratory by developing and maintaining the Branch Quality Management System and ensuring adherence to quality guidelines and standards.
Enterprise SoftwareConsultingInformation TechnologyManagement ConsultingProject Management
No H1B
U.S. Citizen Only
Responsibilities
Participate in the maintenance of the Branch Quality Management System and adherence to applicable guidelines and requirements established by Clinical Laboratory Improvement Amendments (CLIA), the Food and Drug Administration (FDA) and the International Organization for Standardization (ISO)
Provide direct laboratory support for the implementation of quality system activities:
Monitor equipment calibration and preventive maintenance activities
Coordinate equipment maintenance with vendors as applicable
Maintain records (training, equipment, monitoring records, NCEs etc.) in accordance with quality standards
Assist laboratories with documentation and investigation of nonconformances
Monitor competency assessments and proficiency testing
Under the direction of the Branch Quality Team, work directly with laboratory staff to implement and ensure quality system requirements are met
Assist branch quality team in performing periodic internal quality audits
Assist branch quality team in development and collation of data for branch quality management reviews
Work with branch quality team to ensure that all aspects of the branch QMS are developed, documented, implemented, and maintained
Analyze, review, revise, and/or interpret the data and prepare scientific reports, laboratory Standard Operating Procedures (SOPs), training materials, minutes, summary reports, abstracts, manuscripts, presentations, and other documents related to laboratory testing, training, specimen management, safety, and quality
Assist in placing orders, receiving, and ensuring that packing slips are maintained/uploaded, and all relevant trackers are updated
Manage in-processing of reagents and supplies, assist in QC and labeling, and with the supplies and reagents inventory
Assist/manage disposal of expired/hazardous waste
Qualification
Required
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 applicable Quality Management Plan guidelines and requirements. (CLSI, ISO, CLIA, FDA)
Ability to communicate effectively orally and in writing
Strong CAPA, audit, and complaint systems experience is essential
Strong knowledge of established quality and reliability assurance practices, standards, and procedures, their content, and applications as applied to quality systems, manufacturing processes, and production methodology
Strong knowledge of Quality Control (QC) manuals, QC audit procedures, document package requirements, and overall Quality Assurance (QA) criteria specific to inspection reports, parts lists, revision levels, change orders, model numbers, classifications of defects, process test specifications, statistical sampling levels, acceptable quality levels, and others as applicable
Experience using computer software packages including Microsoft Word, Excel, and PowerPoint
The candidate must possess excellent oral and written communication skills in English
Must be a United States citizen or permanent resident or have authorization for employment in the United States
Preferred
Excellent oral and written communication skills
Comfort working in a fast paced and highly interdisciplinary environment
Experience working with a diverse interdisciplinary team
Company
ASRT, Inc.
ASRT, Inc.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase