Amber Kimbrew
St. Petersburg,FL
Summary
Quality assurance strategist with 8+ years of experience in regulated laboratory and manufacturing environments, specializing in ethical compliance, process optimization, and cross-functional systems design. Adept at translating complex standards (CLIA, FDA, ISO, 508) into stakeholder-friendly protocols. Passionate about sustainable, mission-aligned work and quality systems that uphold both technical integrity and customer trust. Seeking to support Quince’s mission with data-informed quality operations and an uncompromising eye for ethical sourcing and product excellence.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Quality Control Manager, QM Specialist II
Centers for Disease Control and Prevention (CDC)
01.2021 - Current
- Designed and implemented risk-based quality systems across CDC labs, including root-cause frameworks, and stakeholder training aligned with CLIA, FDA, and CDC standards.
- Led the documentation lifecycle for compliance assets: quality manuals, UATs, SOPs, and design history files.
- Supported cross-functional alignment between engineering, sourcing, and regulatory teams to manage new instrument integration with minimal operational disruption.
- Developed performance dashboards and automated workflows that decreased process time and reduced document version errors.
- Delivered high-stakes briefings on quality metrics, lab safety, and bioterrorism preparedness to internal and external public health agencies.
- Identify gaps, lead, and support the implementation of systems focused on improving workflows, documentation management, and reducing laboratory processing time.
- Authored and contributed to guidance documents, SOPs, and validation protocols to support regulatory compliance initiatives, ensuring adherence to CLIA, FDA, and CDC standards.
- Collaborated with cross-functional teams on FDA submission processes, facilitating clear communication of regulatory requirements, and contributing to Design History Files for multiple 510(k) approvals.
- Optimized onboarding processes for new systems, enhancing team efficiency, and reducing training time.
- Tracked and continually monitored the power-automate internal Inventory Management (NIMS) system for CDC labs. Acted as the primary day-to-day contact for laboratory POCs, providing support, troubleshooting, and effectively triaging responsibilities to team members to resolve issues encountered.
- Assess and advise on CLIA compliance practices within the National Center for Immunization and Respiratory Diseases (NCIRD), CDC. Ensured that standard operating procedures are followed by process analysis, and provided appropriate guidance to improve existing processes and policies, as well as to formulate new ones.
- Ensure adherence to pre- and post-analytical specimen shipping and storage methods, as defined by specimen stability studies and aligned with good laboratory practices.
- Ensure tested specimen types align with the defined conditional parameters established by specimen stability studies.
- Document records of the comparison of validation, including the number and identification of samples, reagents, instrument number, and results obtained.
- Managed project timelines, dependencies, and resources to deliver projects on time and within scope.
- Experience managing strategic vendor relationships and collaborating with diverse, cross-functional audiences.
- Verify that Non-Conforming Event (NCE) and Document Change Request (DCR) processes have been properly documented, tracked, and published in accordance with established procedures.
- Collaborate with colleagues and IT specialists to modernize and simplify the external CCP SharePoint site, and automate the internal DCR and NCE database processes.
- Identify shortcomings in current workflows, and provide consultation for improvement recommendations.
- Communicate with leadership to define objectives, and conceptualize end-user needs.
- Coordinate with colleagues and software development teams to create or update workflows based on intended use and needs.
- Draft user acceptance testing (UAT) script instructions, and delegate, document, and report tasks through implementation.
- Present and train staff on the application and utility of new processes, or workflows.
- Collaborate with colleagues to draft or revise existing government guidance documents, forms, and procedures to ensure CLIA and 508 compliance, prior to laboratory adoption within NCIRD and other centers at the CDC.
- Coordinate and present in center-wide and agency-wide meetings on a range of laboratory safety, and laboratory CLIA-specimen management topics at the CDC.
- Responsible for coordinating the assembly of concept and feasibility reports, test plans, project plans, product requirement reviews, product and development risk analyses, design input/output verification and validation, and product support plans.
Molecular and Medical Technologist
Bako Diagnostics
05.2020 - 10.2021
- Draft and present departmental business plan analysis including performance metrics, lab safety adherence, internal quality scores, Individualized Quality Control Plan (IQCP) equipment maintenance, and production cost management.
- Assess and advise on numerous laboratory safety and quality regulations (including CLIA, CAP, and Laboratory Response Network (LRN)).
- Turnaround time monitoring, documentation of statistical data, evaluation of identified pathogens, and assessment of corrected reports.
- Ensure proper reporting of missing patient identifiers, inappropriate transport media, expired transport vessels and client requested diagnostic methods in MicroPath.
- Perform and assign CAP, CLIA, and LRN hypothetical patient 'kits.' Review and understand proper reporting techniques to Public Health entities in response to encounter bio-terror pathogens.
- Assign, result, and report to MicroPath for upload into PowerPath for external client viewing.
- Document records of comparison of validation including number and identification of samples, reagents, instrument number, and results obtained.
- Ensure observed patient test results are within the established reportable range as reported by validation study records.
- Ensure adherence of pre- and post-analytical specimen storage methods as is described in SOPs and aligned with good laboratory practices.
- Coordinate with vendors, installation-engineers, in-house maintenance, IT, and technologists to efficiently accept new instruments and subsequent training.
Graduate Research Assistant
Georgia State University
01.2020 - 01.2021
Research Student
Georgia Gwinnett College, Green Law, Centers for Disease Control and Prevention, Georgia State University
01.2016 - 01.2020
- Analyzed data from surveys, interviews, focus groups, and observations to develop insights into the study population's behavior or attitudes.
- Maintained accurate records of all data collected during the course of a study.
- Created visualizations such as graphs or charts to help convey complex information in an easily understandable way.
Education
Master of Interdisciplinary Science - Biomedical Enterprise
Georgia State University
Bachelor of Science - Chemistry, Biochemistry
Georgia State University
Laboratory Quality Management System Certificate -
Clinical and Laboratory Standards Institute (CLSI)
Georgia State University
Georgia Gwinnett College
Skills
- System Implementation
- Regulatory Compliance
- Project management
- Technical writing
- Process Optimization
- Cross-functional Collaboration
- Clinical Healthcare Partnerships
- Root-cause Analysis
- Microsoft Office suite products
- SmartSheet
- Strong collaboration
- Effective communication
- Analytical skills
- Problem-solving skills
- Technical Writing
- Regulatory Writing
- SOP development
- Validation reports
- Regulatory submission documents
- Design History Files
- Project plans
- Technical reports
- Data analysis
- Metrics analysis
Certification
- Laboratory Quality Management System Certificate, Clinical and Laboratory Standards Institute (CLSI)
- Ethics of AI, Politecnico di MIlano
Skills
System Implementation, Regulatory Compliance, Project management, Technical writing, Process Optimization, Cross-functional Collaboration, Clinical Healthcare Partnerships, Root-cause Analysis, Microsoft Office suite products, including Word, Excel, PowerPoint, and SharePoint, SmartSheet, Strong collaborator with proven ability to communicate and present effectively, Strong analytical and problem-solving skills, ability to deliver on objectives in a timely manner
Affiliations
- Reading
- Scuba-diving
- Gardening
- Painting
References
References available upon request.
Timeline
Quality Control Manager, QM Specialist II
Centers for Disease Control and Prevention (CDC)
01.2021 - Current
Molecular and Medical Technologist
Bako Diagnostics
05.2020 - 10.2021
Graduate Research Assistant
Georgia State University
01.2020 - 01.2021
Research Student
Georgia Gwinnett College, Green Law, Centers for Disease Control and Prevention, Georgia State University
01.2016 - 01.2020
Master of Interdisciplinary Science - Biomedical Enterprise
Georgia State University
Bachelor of Science - Chemistry, Biochemistry
Georgia State University
Laboratory Quality Management System Certificate -
Clinical and Laboratory Standards Institute (CLSI)
Georgia State University
Georgia Gwinnett College
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