Description:
JOB TITLE: Quality Management Specialist
POSITION NUMBER: 2509-18480-QMS-001
POSITION LOCATION: Atlanta, GA, USA
ANTICIPATED START DATE: Two weeks after candidate identification
TRAVEL: As required to fulfill the responsibilities of the position
ASRT, Inc. provides scientific, information management, management consulting, bioinformatics, and administrative program support to the Centers for Disease Control and Prevention (CDC) and other Federal and private sector clients. The successful candidate will be a full-time employee of ASRT, Inc. and will be assigned to the Division of Foodborne, Waterborne, and Environmental Diseases (DFWED), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), at the CDC, 1600 Clifton Road, Atlanta, GA, to provide scientific and technical support for the EDLB.
SCOPE OF WORK
The Quality Management Specialist will provide scientific and laboratory support to the Division of Foodborne, Waterborne and Environmental Diseases (DFWED) in its preparedness and response to foodborne and diarrheal diseases in the United States and abroad.
MAJOR DUTIES AND RESPONSIBILITIES
- Perform reference testing on foodborne bacterial pathogens in accordance with safety, and agency requirements.
- Performs laboratory activities to support quality assurance and quality control programs in the Branch
- Assist with the drafting and reviewing standard operating procedures (SOPs), quality management system (QMS) and relevant laboratory safety documents. (3) Analyzes whole genome sequence (WGS) data of bacterial isolates as part of PulseNet quality assurance and quality control programs and works collaboratively with members of QA/QC workgroup on PulseNet's certification and proficiency testing program
- Actively participates in day-to-day laboratory procedures as part of the PulseNet Outbreak and Response Surveillance Team (PROST)
- Assists with outbreak response activities during national and international foodborne disease outbreaks.
- Prepares and delivers clear, concise, and accurate reports and presentations for colleagues and collaborators at internal and external meetings. Communicates with laboratory leadership as issues arise.
Requirements:
MINIMUM QUALIFICATIONS
Education and Experience:
- 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.
Required:
- 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
Desirable:
- Excellent oral and written communication skills
- Comfort working in a fast paced and highly interdisciplinary environment
- Experience working with a diverse interdisciplinary team
Language Skills:
- The candidate must possess excellent oral and written communication skills in English.
REQUIREMENT: Must be a United States citizen or permanent resident or have authorization for employment in the United States.
SALARY: Commensurate with qualifications and experience.
To apply for this position:
- If you are viewing this position on the ASRT Career page, please click on the "Apply" button.
- If you are viewing this position on a site other than the ASRT Career page, you may use the "click to apply" link, or you may apply by visiting our Career page and searching for the job title and position number listed at the top of this job posting.
- To view all of our open positions and to apply to job openings in which you may be interested, please visit our Career page at https://www.asrtinc.com/careers.
EEO/vets/disabled
Equal employment opportunity, including veterans and individuals with disabilities.
PI277797997
