Description:
JOB TITLE: Laboratory Quality Specialist
POSITION NUMBER: 2508-17711-LQS
POSITION LOCATION: Atlanta, GA, USA
ANTICIPATED START DATE: Three to six 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 Respiratory Diseases Branch (RDB), National Center for Immunization and Respiratory Diseases (NCIRD), at the CDC, 1600 Clifton Road, Atlanta, GA, to support to the Quality Management team and M&O team within RDB..
SCOPE OF WORK
The Laboratory Quality Specialist will provide scientific and laboratory support within the RDB, providing support services participate in the development, implementation, and maintenance of the Branch Quality Management System, as well as adherence to applicable guidelines and requirements.
MAJOR DUTIES AND 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).
- Improve safety and quality of lab through assistance with risk assessments on new and current laboratory procedures.
- Attend meetings to strategize improvements in lab safety/quality and communicate changes in safety protocols and/or new safety training from the division to Pneumonia Response and Suveillance Laboratory and Streptoccus Laboratory staff.
- Assist in the updating of signs, emergency contact information, staff contact information, evacuation routes, and other pertinent safety information.
- Serve as a point of contact for biosafety cabinet concerns and assure that all biosafety cabinets (BSC) are up to date through communication with safety help desk in scheduling annual maintenance.
- Record and address violations (if any) during inspection walk-throughs.
- Participate in an overall effort to verify that all personnel are following the most current lab safety protocols. The contractor shall participate in providing safety training for new and returning personnel.
- In the event CDC activates the emergency operations center or RDB is tasked to support an extended public health emergency, the requirements for daily activities may change to support the public health emergency. Following consultation with and approval by the contracting officer, the contractor shall adapt laboratory safety and quality services tasks to public health response tasks within the skills, experience, and capacity of the contractor.
- Provide direct laboratory support for the implementation of quality system activities.
1. Monitor equipment calibration and preventive maintenance activities.
2. Coordinate equipment maintenance with vendors as applicable.
3. Maintain records (training, equipment, monitoring records, NCEs etc.) in accordance with quality standards.
4. Assist laboratories with documentation and investigation of nonconformances.
5. 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.
- Work with branch quality team to ensure that all aspects of the branch QMS are developed, documented, implemented, and maintained.
Requirements:
MINIMUM QUALIFICATIONS
Education and Experience:
- Bachelor's or master's degree in microbiology, biology, chemistry, or basic medical science.
- Minimum of 2 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.
- Knowledge of CAPA, audit, and complaint systems experience is essential.
- 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.
- 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.
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