Quality Management System (QMS) Specialist

BeVera Solutions LLC•Atlanta, GA

4h•Onsite

About The Position

BeVera Solutions, LLC is seeking an experienced Quality Management System (QMS) Specialist to support a government agency with the DHP goals to reduce new HIV infections through supporting clinical studies, surveillance and implementation research. The Laboratory Branch (LB) conducts liquid chromatography tandem mass spectrometry (LC-MS/MS) testing of biological specimens to detect and quantitate antiretroviral and antimicrobial drugs using quantitative and qualitative assays to provide objective measures of drug use for HIV treatment and prevention. This role is part of a pre-award candidate search for an upcoming federal government contract.

Requirements

BS in Medical Technology, Biological Sciences, or a related field with education pertinent to clinical or research laboratory operations and regulations required.
Relevant clinical or research laboratory experience in implementing, managing, and maintaining quality management systems required, or demonstrable laboratory regulatory expertise gained through coursework or professional experience.
Experience developing processes and monitoring the performance of laboratory standard operating procedures in accordance with laboratory policies and recognized quality guidelines.
Familiarity with one or more of the following: CLSI, College of American Pathologists (CAP), International Organization for Standardization (ISO), or an equivalent accreditation body.
Must be able to pass a background investigation commensurate with position sensitivity designation.
Must be able to comply with HSPD-12 and obtain PIV credentials.
Must be able to obtain and maintain all required vaccinations and medical clearances for CDC laboratory access, including Hepatitis B series, TB screening, Tdap, MMR, Varicella, and annual influenza vaccination.
Excellent written communication skills, with emphasis on writing, data communication and visualization skills.
Attention to detail and commitment to high quality/error free deliverables.
Experience in implementing best practices in a public health setting.
Experience working with/in the CDC.
Must be a U.S. citizen.

Nice To Haves

Experience with document control and electronic quality management systems preferred.

Responsibilities

Support the implementation of mandated compliance with CDC's Quality Manual for Microbiological Laboratories (QMML) and Clinical Laboratory Improvement Amendments (CLIA) requirements.
Collaborate with the quality manager and safety manager to implement and manage QMS and CLIA.
Maintain current knowledge of QMS status, issues, training, and progress related to CDC's Quality Manual for Microbiological Laboratories (QMML), Clinical Laboratory Improvement Amendments (CLIA), Clinical and Laboratory Standards Institute (CLSI), and other applicable national and international standards.
Ensure and manage the effective implementation of quality policies, processes, and procedures utilizing the 12 Quality System Essentials (QSEs).
Perform document control and support the management of quality-related procedures and forms.
Maintain, update, and track documents and records utilizing CDC's electronic quality management system (eQMS).
Coordinate and communicate with branch personnel and relevant CDC offices regarding procedures, schedules, and related matters.
Administer equipment maintenance and calibration activities, including obtaining vendor quotes, submitting and managing forms and requests through CDC's applicable purchase systems, and arranging vendor service calls.
Investigate nonconformance events and develop and implement corrective actions.
Conduct quality assessments in accordance with quality review plan criteria to evaluate compliance with applicable research and clinical laboratory policies, processes, procedures, and standards.
Comply with all CDC safety policies, procedures, and quality management system requirements.