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

Goldbelt Professional Services specializes in providing expert resources for Public Health missions including scientific, technical, and administrative support from junior staff to high-level subject matter experts. Research and data driven, Goldbelt Professional Services' experts create solutions customized to the client's needs.

Summary:

As a Project Support Specialist I the candidate shall l provide and carry out a broad array of scientific and programming activities.

Essential Job Functions:

• Compliance
  • 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.
  • Conduct routine audits of 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
• Equipment Maintenance Coordination
  • Work with property managers, laboratory managers, and the administration team to track branch equipment
  • 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. Ensure records as are kept when equipment maintenance or repair has occurred.
  • 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.
  • Serve as one of the branch training administrators and assist the training coordinator in tracking trainings as needed.
  • Assist the training coordinator in gathering documents required for laboratory access packets
  • Act as alternate property custodian on PRB property accounts.
• Perform property management of lab and office equipment.
  • Account for all personal property within your assigned custodial area, and be sure PMIS records are current and accurate at all times.
  • 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.
  • Identify and 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.
• Microbiology Services
  • 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.

Necessary Skills and Knowledge:

• 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.
• Experience with quality management systems, internal audits, document control, training management, or regulatory compliance activities.
• 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.