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Quality Management System (QMS) Specialist

BeVera Solutions

Atlanta, Georgia, United States · 정규직

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Bachelor's degree in Medical Technology, Biological Sciences, or related field
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Applicants must be U.S. citizens capable of obtaining necessary security clearances and medical clearances required by CDC laboratory access. They should be able to work full-time onsite in Atlanta with no telework.
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About BeVera Solutions, LLC

BeVera Solutions is an expanding public health and professional services firm dedicated to delivering innovative solutions to federal and state agencies. The company specializes in mission-critical program assistance across program management, communications, acquisition, data analytics, and public health initiatives. With a people-centric culture promoted by its CEO, BeVera supports competitive remuneration and meaningful assignments. The organization has been recognized as one of Atlanta's top workplaces for three consecutive years (2024-2026) by the Atlanta Business Chronicle, emphasizing integrity, excellence, and teamwork.

Job Role Overview

The Quality Management System Specialist will assist a government agency focused on decreasing new HIV infections by supporting clinical studies, surveillance, and implementation research. This role involves supporting the Laboratory Branch in their work with LC-MS/MS testing of biological samples for antiretroviral and antimicrobial drug measurements indicative of HIV treatment and prevention.

Responsibilities

  • Collaborate with quality and safety managers to implement and oversee the Quality Management System (QMS) and comply with CLIA regulations.
  • Stay updated on the status, challenges, training, and progress related to CDC's Quality Manual for Microbiological Laboratories (QMML), CLIA, CLSI, and other relevant standards.
  • Ensure effective execution of quality policies and procedures based on the 12 Quality System Essentials (QSEs).
  • Manage document control and support quality-related records and forms management.
  • Maintain and update electronic quality management system records per CDC standards.
  • Coordinate communications and scheduling with branch personnel and CDC contacts.
  • Handle equipment maintenance and calibration logistics, including vendor interactions and purchase requests through CDC purchasing systems.
  • Investigate nonconformance issues and develop corrective action plans.
  • Conduct quality assessments aligned with quality review plans to verify compliance with laboratory policies and standards.
  • Adhere strictly to CDC safety and quality management policies.

Qualifications

  • Bachelor's degree in Medical Technology, Biological Sciences, or related fields pertinent to clinical or research laboratory operations and regulations is required.
  • Proven clinical or research lab experience in establishing and managing quality systems, or equivalent regulatory expertise through coursework or employment.
  • Experience developing and monitoring laboratory standard operating procedures in line with policies and quality standards.
  • Familiarity with standards such as CLSI, CAP, ISO, or comparable accreditation frameworks.
  • Preferred experience with document control systems and electronic quality management software.
  • Ability to pass a background check appropriate to the position's security requirements.
  • Capability to comply with HSPD-12 standards and obtain PIV credentials.
  • Must satisfy CDC lab medical requirements including vaccinations and health clearances (Hepatitis B, TB, Tdap, MMR, Varicella, flu vaccine).
  • Must be a US citizen.
  • Strong written communication skills focused on writing, data presentation, and visualization.
  • Detail-oriented with dedication to delivering error-free work.
  • Experience applying best practices in public health environments.
  • Previous experience working with or within the CDC is required.
  • Work schedule consists of a 40-hour week, Monday through Friday, 8:00 AM to 4:30 PM, onsite only without telework.

Additional Information

All applicant information is confidential per Equal Employment Opportunity guidelines. The employer practices non-discrimination and provides equal opportunities regardless of race, religion, color, gender, national origin, age, veteran status, sexual orientation, marital status, family structure, medical condition, or disability, as long as the essential job functions can be performed with or without accommodations.

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