KATHLEEN ROBERTS
Florence,KY
Summary
Skilled Quality Management Professional with 7 years of documented quality control success. Proficiently managing a QMS based on ISO9001:2015 standard. Develops specific and measurable goals, improvements and standards to continuously improve quality using LEAN & Six Sigma practices.
Successfully audits and maintains product accuracy and timely delivery resulting in customer satisfaction. Initiates and drives quality-related SOP writing, CAPAs and Deviations, SCARs and enforces procedural adherence.
Overview
11
11
years of professional experience
Work History
Quality Supervisor
A. O. Smith
07.2022 - Current
- Managed an ISO9001:2015 certified QMS for a major frit manufacturing site.
- Promoted a proactive approach to risk management within the organization, mitigating potential concerns before they escalated into larger issues.
- Reviewed and dispositioned all non-conforming materials. Reduced scrap by 31% within first year of managing dispositions through data analytics and testing of all non-conforming materials.
- Analyzed trends and capabilities of processes using statistical analysis to minimize variation.
- Increased efficiency of the QMS and drove process standardization by regularly reviewing procedures and making updates based on changing business needs or industry advancements.
- Championed data-driven decision making by conducting regular reviews of performance metrics and adjusting strategies accordingly.
- Ensured consistent delivery of high-quality products by closely supervising production teams throughout manufacturing processes.
- Managed root cause analysis investigations, determining underlying issues in product failures and implementing corrective actions as necessary.
- Led continuous improvement initiatives by actively seeking opportunities for process optimization and cost reduction.
- Facilitated cross-functional team collaboration, ensuring seamless communication between departments regarding quality matters.
- Conducted thorough audits to ensure adherence to industry standards and regulatory requirements.
- Enhanced customer satisfaction by monitoring and addressing customer complaints promptly and efficiently.
- Streamlined production processes by identifying areas for improvement and implementing corrective actions.
Clinical Lab Scientist
Amazon STS Lab2
06.2020 - 10.2022
- Was a pivotal member of a start-up lab in response to the COVID-19 pandemic as a Clinical Lab Scientist.
- Conducted experiments in laboratory environment for developing a new assay for detection of SARS-CoV-2 utilizing RT-PCR.
- Applied strong leadership talents and problem-solving skills to maintain team efficiency and organize workflows to meet any daily demand.
- Supervised a team of 25 people on a daily basis to accomplish production goals and troubleshoot any issues.
- Documented changes during experiments, noting unexpected issues arising during research activities.
- Achieved under-budget and on-time project management to adhere to project goals and deadlines.
- Updated quality control standards, methods and procedures to meet compliance requirements.
- Contributed to the submission of an EUA process to the FDA by conducting multiple experiments and writing SOPs.
- Wrote and implemented new rework procedures and SOPs to standardize processes and streamline workflow.
- Managed and archived quality documentation and participated in internal and external quality audits such as CAP and CLIA.
- Developed and delivered up-to-date training information to enhance employee performance, boosting employee efficiency.
- Assessed staff performance and training effectiveness, capitalizing on opportunities to develop new training programs and improve existing ones.
Quality Technician
Safran Landing Systems
02.2019 - 06.2020
- Sampled carbon materials to ensure the reliability of the manufacturing process by performing material testing, chemical analysis, and inspection instructions to validate production processes and materials at each stage of manufacturing.
- Made recommendations on ways to improve testing procedures, production processes and training.
- Inspected finished products for quality and adherence to customer specifications.
- Prepare topics for Material Review Board meetings and assist in identifying the root cause of non-conformance.
- Ensure lab equipment is in working condition through calibration and maintenance.
- Assisted in several audits by multiple agencies including, FAA, Boeing and 5S principles.
- Specifying quality requirements of raw materials with suppliers.
Extraction Specialist
Ethos Laboratories
03.2017 - 01.2019
- Accession samples into the Laboratory Information System (LIS), and aliquot with precision to a 96-wellplate.
- Perform solid phase extractions on urine, plasma and oral fluids, as well as be able to perform weekly maintenance on instruments and trouble shoot any issues.
- Performed self-inspections according to CAP standards as an inspector.
- Helped develop and write new SOPs to be utilized for more efficient work.
- Organized SDS for all chemicals in the laboratory and ensured proper laboratory safety.
- Practiced ELISA to test patient samples using EIA (Olympus 2700).
Pharmacy Technician
Kroger Pharmacy
10.2013 - 10.2018
- Responsible for providing pharmaceutical information to patients, and communicating patient concerns with pharmacist.
- Verified patient data and billing information to discover and resolve erroneous bills due to system errors.
- Performed various pharmacy operational activities with strong commitment to accuracy, efficiency and service quality.
Education
Bachelor of Science - Chemistry
Northern Kentucky University
Highland Heights, KY05.2016
Skills
- Quality Management - ISO9001:2015
- Root Cause Analysis, CAPA, SCAR
- Troubleshooting using LEAN & Six Sigma Principles
- Good Laboratory Practices (GLP) & Good Manufacturing Practices (GMP)
- SOP Writing & Document Control
- Product Development and Project Management
- Training and Mentoring
- ASQ - Certified Quality Auditor
- Systems: Windows, SAP, LIS
- Bilingual: Swedish/English
Timeline
Quality Supervisor
A. O. Smith
07.2022 - Current
Clinical Lab Scientist
Amazon STS Lab2
06.2020 - 10.2022
Quality Technician
Safran Landing Systems
02.2019 - 06.2020
Extraction Specialist
Ethos Laboratories
03.2017 - 01.2019
Pharmacy Technician
Kroger Pharmacy
10.2013 - 10.2018
Bachelor of Science - Chemistry
Northern Kentucky University
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