Project Support Specialist I (Lab Quality, Compliance, and Microbiology Services)

Responsibilities

• Conduct routine audits to determine if newly implemented practices and policies are being followed.
• Update documents and forms, and make sure they are available to PRB staff at all times.
• Check updates to documents for required training to PRB staff, and document trainings when they occur.
• Audit branch quality management systems and work with PRB regulatory affairs manager to audit required documents for select agent compliance.
• Review CLIA compliance.
• Review the overall quality system to confirm that the branch maintains agency requirements.
• Identify records and determine schedule for review of records, if necessary.
• Schedule destruction of records when mandatory retention time has been met. Ensure a certificate of destruction has been generated after the records have been appropriately destroyed.
• Coordinate equipment maintenance with property managers, laboratory managers, and the administration team.
• Create and maintain preventative maintenance schedules and upload all documentation into eQMS (ComplianceQuest).
• Determine which equipment requires maintenance agreements and assign a schedule to ensure equipment contracts are submitted in a timely manner.
• Maintain an accurate inventory of all PRB equipment.
• Maintain a database of points of contact for equipment, who will be responsible for routine maintenance and training.
• Assist the training coordinator in tracking trainings as needed.
• Assist the training coordinator in gathering documents required for laboratory access packets.
• Perform property management of lab and office equipment.
• Initiate or process documents affecting equipment, and ensure all property movement into or out of the custodial area is documented properly.
• Complete HHS form 439 (Personal Custody Property Record) when end-users remove items from CDC’s campus for telework, field use or conferences.
• Continuously review records to be sure that property is maintained properly, protected, and used only for official purposes.
• Report any underutilized or unneeded property.
• Report any property determined to be lost, damaged, missing, or stolen immediately to the Security Operations Center at 404-639-2888 or cdcsecurit@cdc.gov, the OPAO, and LPMSO.
• Submit a complete, accurate, timely Report of Survey (ROS)pdf icon to the OPAO.
• Assist in the annual physical inventory and joint inventories for account transfer, and conduct your own physical inventory when appropriate.
• Be sure exit clearance procedures for all assigned property are followed before an end user’s departure.
• Be sure acknowledgments and transfers are fully supported and entered in PMIS promptly.
• Attend regularly scheduled property training sessions.
• Work in the CLIA BSL-2 Laboratory to accession specimens, prepare for processing, and perform molecular assays as needed.
• Aid in molecular testing (PCR).
• Provide assistance for eLIMS as needed.

  Qualifications

  • Working knowledge of laboratory quality management systems, regulatory compliance, document control, records management, and routine audit practices.
  • Familiarity with CLIA requirements, laboratory quality standards, and compliance practices applicable to BSL-2 laboratory operations.
  • Ability to conduct routine audits, identify documentation or process deficiencies, track corrective actions, and verify adherence to established policies and procedures.
  • Experience maintaining controlled documents, training records, retention schedules, certificates of destruction, and other quality or regulatory records.
  • Strong organizational and coordination skills for managing preventive maintenance schedules, service agreements, equipment documentation, and laboratory inventories.
  • Knowledge of property and asset management practices, including equipment tracking, transfers, physical inventories, custodial records, and disposition of excess or damaged property.
  • Experience using electronic quality management, laboratory information, inventory, or asset-management systems; ability to accurately maintain electronic records and databases.
  • Ability to coordinate staff training requirements, maintain training documentation, and assist with laboratory access and onboarding documentation.
  • Basic knowledge of microbiology and molecular laboratory procedures, including specimen accessioning, sample preparation, nucleic acid testing, and PCR.
  • Strong attention to detail, written and verbal communication skills, and ability to work effectively with laboratory managers, property staff, quality personnel, administrative teams, and technical staff.
  • Minimum Qualifications: Associate or Bachelors microbiology, biology, laboratory science, quality assurance, public health, health sciences, or a related field. 3-5 years of relevant experience.
  • Ability to obtain and maintain CDC Public Trust Clearance.
  • Preferred Qualifications: Bachelor’s or Master’s in microbiology, biology, laboratory science, quality assurance, public health, health sciences, or a related field. Approximately 5-7 years of relevant experience in laboratory operations, quality assurance, regulatory compliance, property management, or scientific program coordination.
  • Experience working in a CLIA-regulated clinical or public health laboratory environment.
  • Familiarity with select agent compliance, laboratory biosafety requirements, or other regulated laboratory programs.
  • Experience coordinating preventive maintenance, calibration, service contracts, or inventory for laboratory equipment.
  • Experience with electronic quality management systems such as ComplianceQuest, LIMS/eLIMS, or comparable laboratory information systems.
  • Experience managing government, institutional, or laboratory property inventories and associated accountability documentation.
  • Hands-on experience with specimen accessioning, molecular testing, PCR, or other routine BSL-2 laboratory procedures.
  • Experience supporting multidisciplinary laboratory operations involving quality, compliance, training, equipment, property, and administrative functions.
  • Prior experience with CDC.

  Pay And Benefits

  At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.