Tina L. Buffington-Johnson
Raleigh
Summary
Auditing professional with comprehensive expertise in conducting thorough audits and enhancing compliance processes. Recognized for driving impactful audit results and fostering collaborative team environment. Reliable and adaptable, consistently meeting organizational goals through strategic problem-solving and keen attention to detail.
Overview
25
25
years of professional experience
Work History
Quality Systems Program Administrator
North Carolina Department of Agriculture
01.2015 - Current
- Project Manager responsible for development, maintenance, and improvement of the laboratory quality management systems involved in the Steve Troxler Agricultural Sciences Center for the State of North Carolina Department of Agriculture and Consumer Services which consists of five distinct divisions and four testing laboratories of approximately 275 people covering scientific application of relevant state and international standards for veterinary testing, food and drug testing, pesticides testing, fuel quality testing, and the state's metrology laboratory.
- Interpretation and application of various international and national program standards relevant to each division's laboratory including ISO 17025 for testing and calibration, AOAC International program standards for food and drug testing, NVLAP standards for metrology, and the applicable FDA/USDA CFR's for each division.
- Lead Manager responsible for communicating program requirements through documentation and training to all staff.
- Collaborate with cross-functional teams to identify areas of improvement and implement effective solutions.
- Lead Manager responsible for creation and maintenance of all high-level quality system documentation.
- Manage change control processes effectively, minimizing disruptions to operations while maintaining regulatory compliance.
- Project Manager responsible for selection and implementation of program wide systems including quality management system electronic management software solutions and environmental monitoring software solutions.
- Coordinate development and implementation of new standard or in-house developed laboratory methods based on customer requests or technology advancements as required (for example MALDI-TOF and whole genome sequencing).
- Responsible Project Lead to develop operational procedures for newly built BSL-3 laboratory space including operation of Vaporized Hydrogen Peroxide equipment for large room and small contained space decontamination events.
Third Party Accreditation Lead Auditor
Various - Primarily A2LA
05.2016 - Current
- Secondary employment as a lead assessor for US third party accreditation bodies - primarily as a consultant for the American Association for Laboratory Accreditation.
- Successfully passed examination for independent lead auditor in the areas of ISO 17025 - Testing and Calibration requirements, ISO 20387 - Biobanking standards, ISO 17043 - Proficiency Testing Provider standards, ISO 17034 - Reference Material Producer standards including applicable industry requirements.
- Expert level designation in all standards and areas of testing assessed in various entities.
- Over 9 years of third party lead assessor experience auditing various entities of private, state, and federal laboratories to applicable standards for international accreditation.
- Conducted over 300 accreditation assessments during my time as a third party accreditation assessor including virtual and on-site assessments.
- Team leader status for assessments of large size where more than one assessor is required.
- Collaborated with cross-functional teams to ensure comprehensive audits and accurate reporting.
- Work with various accrediting bodies to develop internationally delivered training classes.
- Develop strong relationships with clients by maintaining open lines of communication throughout the audit process.
- Adapt quickly to new industries and client requirements, demonstrating versatility in approach and methodology when conducting audits.
- Foster trust among clients through transparent communication about audit findings and recommendations.
- Provide expert guidance on industry regulations and best practices to both colleagues and clients alike.
Quality Manager - Veterinary Division
North Carolina Department of Agriculture
05.2015 - 06.2021
- Managed root cause analysis investigations, determining underlying issues in testing failures and implementing corrective actions as necessary.
- Facilitated cross-functional team collaboration, ensuring seamless communication between departments regarding quality matters.
- Evaluated quality problems and performed assessments to identify and resolve issues.
- Conducted thorough audits to ensure adherence to industry standards and regulatory requirements, maintaining compliance consistently.
- Mentored and encouraged employees to strive for excellence while fostering professional growth.
- Coordinated and oversaw periodic audits to evaluate quality and address non-conformances.
- Provided training to employees on best practices in quality management, fostering a culture of excellence within the organization.
- Updated quality control standards, methods, and procedures to meet compliance requirements.
- Improved quality processes for increased efficiency and effectiveness.
- Increased customer satisfaction through adherence to quality standards and customer requirements.
- Promoted a proactive approach to risk management within the organization, mitigating potential concerns before they escalated into larger issues.
- Led continuous improvement initiatives by actively seeking opportunities for process optimization and cost reduction.
- Increased efficiency of the QMS by regularly reviewing procedures and making updates based on changing business needs or industry advancements.
- Mentored junior staff members in quality management principles, fostering professional growth among team members.
Laboratory Medical Specialist
North Carolina Department of Agriculture
01.2014 - 01.2015
- Supervisor responsible for supervising 8 technician positions in the North Carolina Veterinary Diagnostic Laboratory System for the Virology section.
- Lead Manager responsible for scheduling and performing disease surveillance testing for several pathogens of interesting for the state of North Carolina as well as federally funded programs (such as Avian Influenza, Swine Influenza, and Pseudorabies).
- Responsible for administering programs with diseases involving public health concerns (zoonotic) including meeting any program reporting requirements and working with public health counterparts under the Incident Response Framework and Emergency Management Programs.
- Direct supervisor responsible for maintenance and development of standard operating procedures for work compliant with BSL-2 and BSL-3 program requirements when necessary for viral pathogens.
- Expert in test technologies for virus isolation, ELISA, virus neutralization, hemagglutination inhibition, agar gel immunodiffusion and Real-Time PCR (RT-PCR) for mammalian and avian viruses.
- Lead individual responsible for creation and revision of procedures to maintain compliance with the quality management system and regulatory standards.
- Implemented process improvements with the section supervisor to increase efficiency and quality within the Virology section.
- Address nonconformance issues within the requirements of the quality management system.
- Directly responsible for training new personnel in all technical and quality aspects of the Virology section.
Quality Coordinator (GS-13)
U.S. Department of Agriculture
01.2006 - 01.2014
- National Veterinary Services Laboratories Coordinator (Project Manager) responsible for development and delivery of the quality management program at the National Veterinary Services Laboratories (NVSL), US Department of Agriculture, encompassing diagnostic testing, calibration laboratory services, reagent production, proficiency test production, biobanking and administrative services (approximately 350 federal employees in two separate locations).
- Team leader responsible for successful efforts to implement a quality management system and achieve third party accreditation to ISO/IEC 17025 (testing and calibration) under the Veterinary Laboratory Accreditation Program by the American Association for Laboratory Accreditation (A2LA) for biological assays, chemical assays, and calibration (standard) services.
- Oversight for implementation and compliance with any applicable 9CFR regulations including federal administration of regulatory programs.
- Project Manager responsible for exceeding US Department of Agricultural goals for laboratory accreditation by accrediting over 80% of services offered (385 tests) within 3 years, 2 years ahead of schedule.
- Authored accreditation program requirements with the American Association for Laboratory Accreditation (A2LA) for the first veterinary program requirements for ISO 17025 accreditation of veterinary laboratories and led the NVSL to become the first laboratory accredited by A2LA under the veterinary program requirements.
- Team member responsible for planning One Health initiatives to enhance collaboration efforts between the NVSL and the Center for Disease Control (CDC) counterparts.
- Lead point of contact in providing information and assistance in benchmarking activities undertaken by the CDC for development of an ISO/IEC accredited quality management program.
- Authored the OIE (International Organization for Animal Health)Laboratory Quality Chapter in the 2012 edition of the Terrestrial Manual.
- Served as a team member in planning emergency response plans at all NVSL facilities for various challenges throughout my career (pandemic flu response, avian flu response), coordinated efforts to build national testing capacity of the National Animal Health Laboratory Network (NAHLN).
- Project Manager responsible for coordinating with state and international laboratories to aid in developing quality management systems, providing training, and obtaining accreditation.
- Team Leader of five quality managers across Pathobiology, Virology, Bacteriology, Foreign Animal Disease, and Calibration Laboratories with the overall responsibility to ensure consistent and meaningful application of the quality management program across all areas of the NVSL.
- Project Manager responsible for selection, development and implementation of MasterControl Solution Packages software as a tool for document management, training, corrective and preventive actions (CAPAs), and process communication with overall system administrative and configuration responsibilities.
- Lead auditor responsible for ensuring all personnel and facilities audits for quality management system compliance across all areas within the 350-person organization and two locations. In-depth knowledge of chemical testing including HPLC, GC-MS, LC-MS, biological testing including molecular techniques, whole genome sequencing, serological tests, bacteriological identification, and isolation including MALDI-TOF, histology and immunohistochemistry, a large-scale media preparation facility and all administrative functions.
- Team Leader responsible for resolving conflicts between areas and quality managers to ensure compliance with the quality program.
- Served as the quality management representative to the highest levels of management within our organization responsible for communication of updates, important issues, convening management reviews, and resolving important customer service issues.
- Project Manager responsible for implementing a successful Six Sigma Greenbelt project resulting in $200k of hard dollar savings by designing an equipment repurposing process to eliminate waste.
Bovine, Porcine, Aquaculture Microbiologist (GS-11)
U.S. Department of Agriculture
01.2003 - 01.2006
- Technical Manager responsible for workload assignments and activities of four technicians for diagnostic testing, reagent production, proficiency test production, establishment, and maintenance of biobanks for program isolates, and equipment calibration/maintenance programs.
- Lead Manager responsible for developing, implementing, and adhering to BSL-3 practices for all work conducted within the section including appropriate personnel protective equipment (PPE) needs (all testing conducted was performed in a BSL-3 environment).
- Technical Manager responsible for development and implementation of standard operating procedures for inventory and use of select agents utilized in the Diagnostic Virology Department.
- Supervisor responsible for training and implementation of select agent rules within the Diagnostic Virology Department.
- Technical Laboratory Manager responsible for leading national outbreak response efforts for Vesicular Stomatitis (zoonotic viral agent with public health concerns) outbreaks in 2004, 2005 and 2006. Established and maintained biobanks of collected isolates during outbreaks.
- Technical Manager responsible for developing better reporting structures within the Incident Management Framework to ensure timely and accurate distribution of results to state and federal partners.
- Led communication of information to field personnel deployed for test sampling activities in the field across the states.
- Technical Manager responsible for input and upkeep of information in a national database to ensure epidemiologists in offsite locations had access to the latest information for building maps of outbreak progression and keeping state partners updated with information as outbreaks progressed across the nation.
- Technical Manager responsible for coordinating the response to a 150-fold increase in testing activities during the Vesicular Stomatitis (zoonotic viral agent with public health concerns) outbreaks including ensuring appropriate reagent production, staging, and appropriate level of personnel trained to handle specific tasks.
- Technical Manager responsible for ensuring field personnel had appropriate access to viral transport medium and supplies levels available on hand at the NVSL to maintain replenishment needs.
- Lead person responsible for developing and implementing documentation practices, instructions compliant with ISO/IEC 17025 requirements. Achieved accreditation status for first tests accredited to ISO/IEC 17025 for the NVSL in 2005 while experiencing disease outbreaks within the section and serving as the primary Technical Lead for those as well.
- Technical Manager responsible for developing and implementing documentation practices, records systems, and establishing best practices for the section.
- Authored the 2006 update of the Vesicular Stomatitis Virus chapter in OIE’s (International Animal Health Organization) Manual of Terrestrial Diseases.
- Lead the NVSL’s presentation of information on Vesicular Stomatitis disease outbreaks data analyzed from current activity at national and international meetings during 2005 and 2006. Participated in departmental after-action reviews on response efforts for 2004, 2005 and 2006.
Senior Technician, Quality Control – Virology
Wyeth Healthcare
05.2000 - 12.2003
- Responsible for testing all modified live virus serial vaccines and components, all live viral seed stocks, and extraneous agent testing for all product components used to produce vaccines.
- Maintained a quality management system compliant with all FDA regulations, USDA regulations, and VLA (European Union) requirements.
- Created and revised standard operating procedures compliant with cGMP and GLP requirements.
- Supervised 5 technicians, responsible for ensuring consistent testing practices.
- Scheduled testing and workloads for five technicians as well as trained all new employees according to good laboratory practices (GLPs) and cGMPs.
- Ensured compliance with all standard operating procedures, outlines of production, and additional company policies within the area.
- Coordinated all on-site inspections, product releases, and new product testing with all other areas.
Education
Bachelor of Science - Biochemistry, College of Agriculture
Iowa State University
Ames, IA05.2000
Skills
- Audit planning and execution
- Internal controls and analysis
- MasterControl administrator level expertise
- Qualtrax administrator level expertise
- Northwest Analyst software
- Time management
- Attention to detail
- Multitasking and organization
- Critical thinking
- Interpretation of regulatory requirements
- Data analytics
Timeline
Third Party Accreditation Lead Auditor
Various - Primarily A2LA
05.2016 - Current
Quality Manager - Veterinary Division
North Carolina Department of Agriculture
05.2015 - 06.2021
Quality Systems Program Administrator
North Carolina Department of Agriculture
01.2015 - Current
Laboratory Medical Specialist
North Carolina Department of Agriculture
01.2014 - 01.2015
Quality Coordinator (GS-13)
U.S. Department of Agriculture
01.2006 - 01.2014
Bovine, Porcine, Aquaculture Microbiologist (GS-11)
U.S. Department of Agriculture
01.2003 - 01.2006
Senior Technician, Quality Control – Virology
Wyeth Healthcare
05.2000 - 12.2003
Bachelor of Science - Biochemistry, College of Agriculture
Iowa State University