Katie Downton
Clifford Township,PA
Summary
Impactful quality manager with natural talents in process improvement, data management and quality control. Safety-focused and forward-thinking with excellent time management and problem-solving abilities.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Quality Manager
The American Society for Nondestructive Testing (ASNT)
Columbus, OH
08.2022 - Current
- Develop, manage, and maintain a Quality Management System (QMS) for conformity to ISO 17024:2012.
- Perform internal and external audits of the QMS.
- Oversee the administration of the Corrective Action program, analyze nonconformances, assist in root cause analysis, process improvements, and preventive actions.
- Plan and assist with conducting internal quality audits, surveillances, and inspections.
- Report audit findings to internal staff and ASNT's outside third-party auditors at ANAB.
- Assist with supplier evaluations and qualifications through audit assessments and inspections described in the quality program.
- Document Management Review Meetings and manage aspects of Management Review inputs and outputs, including CAPAs, audits, appeals, complaints, training, and fulfillment of objectives.
- Build a Document Control software to maintain conformity to ISO 17024:2012.
- Manage volunteer committees.
- Provide quality and process improvement guidance to department staff members.
Quality Engineer
Noble Biomaterials
Scranton, PA
11.2018 - 08.2022
- Analyzed customer complaints and feedback, conducted investigations, and implemented appropriate corrective actions.
- Assisted in the design and implementation of new processes for improved product quality.
- Conducted internal audits to ensure compliance with regulatory requirements and company policies and procedures.
- Evaluated supplier performance against established criteria such as quality standards, delivery times, cost targets.
- Investigated non-conformances using problem solving techniques such as 8D or 5 Why's methodologies.
- Provided guidance in the development of sampling plans for incoming material inspections.
- Collaborated with cross-functional teams to develop solutions that improve overall product quality.
- Performed data analysis to identify root causes of quality issues and developed corrective actions.
- Developed and maintained Quality Assurance procedures in accordance with ISO 9001 standards.
Jr. Chemist, Research and Development
Process Technologies and Packaging
Olyphant, PA
04.2018 - 11.2018
- Documented experiment results accurately using scientific notation when appropriate.
- Maintained records of laboratory activities including test results, sample preparation notes, instrument calibration logs.
- Provided support to other chemists by helping troubleshoot problems or providing assistance with tasks as needed.
- Conducted quality control tests on finished products to ensure compliance with industry standards.
- Manage independent workloads with individual clients and maintain a controlled laboratory notebook and research notes.
- Conducted research in organic chemistry related to drug and makeup design and synthesis.
- Assisted senior chemists in developing new products for clients.
- Monitored inventory of lab supplies and reordered as needed to ensure adequate stock levels were maintained.
Medical Laboratory Technician
Wayne Memorial Hospital
Honesdale, PA
08.2017 - 04.2018
- Conducted microscopic examinations of body fluids such as urine or blood samples.
- Processed specimens using automated analyzers according to standard operating procedures.
- Recorded all test results accurately into the laboratory computer system.
- Maintained a safe working environment by following safety guidelines and regulations set forth by the organization.
- Identified discrepancies in test results that may indicate errors in specimen collection or processing methods.
- Reported any suspected problems with test performance directly to supervisor or clinical staff members.
- Cleaned and sterilized lab area, tools and equipment.
- Maintained clean and fully operational laboratory equipment.
- Performed quality control tests on laboratory equipment and supplies to ensure accuracy of results.
- Performed routine maintenance and troubleshooting on laboratory instruments.
- Verified patient information and collected specimens according to established protocols.
Microbiology Laboratory Analyst I/II
Musculoskeletal Transplant Foundation
Jessup, PA
10.2013 - 06.2017
- Operated laboratory equipment such as centrifuges, autoclaves, incubators and pH meters in accordance with safety guidelines.
- Prepared solutions and reagents according to established procedures for use in experiments or analyses.
- Assisted in troubleshooting issues with lab instruments or processes when needed.
- Reviewed technical documents such as Standard Operating Procedures and Quality Control Plans.
- Collected samples from various sources for testing purposes.
- Monitored inventory levels of supplies necessary for laboratory operations.
- Participated in regular meetings with other scientists to discuss progress.
- Trained new personnel on proper lab safety practices, instrumentation usage, operation protocols and more.
- Performed routine maintenance tasks on lab equipment such as cleaning glassware or replacing parts.
- Implemented corrective actions when discrepancies were identified during quality control checks.
- Used time management and adaptability skills to prioritize and run multiple tests.
- Prepared lab for daily operations by stocking materials and equipment.
- Maintained detailed records of all laboratory activities, including test results and instrument calibrations.
Education
B.S. Biochemistry -
Moravian College
Bethlehem, PA05.2012
Skills
- Compliance Monitoring
- Corrective Actions
- Total Quality Management
- Continuous Improvement
- Issue Resolution
- Document Management
- Statistical process control
- SOP Development
- Internal Auditing
- Supplier Relationship Management
- Quality Management Systems
- Problem-solving abilities
Relatedcourses
- Organic Chemistry
- Genetics
- Molecular Genetics
- Cell Physiology
- Biochemistry
- Physical Chemistry
- Microbiology
Awards
- 3.60 GPA
- Comenius Scholarship
- Dean’s List (5 semesters)
- Gamma Sigma Alpha
Certification
- Certified Quality Auditor (CQA) - American Society for Quality.
- ISO 9001: 2015 Quality Management Systems Internal Auditor Training - International Organization for Standardization.
- ISO 17024:2012 General Requirements for Bodies Operating Certification of Persons Training - International Organization for Standardization.
- Lean Six Sigma Green Belt Training - NEPIRC, Hanover Township, PA.
References
References available upon request.
Timeline
Quality Manager
The American Society for Nondestructive Testing (ASNT)
08.2022 - Current
Quality Engineer
Noble Biomaterials
11.2018 - 08.2022
Jr. Chemist, Research and Development
Process Technologies and Packaging
04.2018 - 11.2018
Medical Laboratory Technician
Wayne Memorial Hospital
08.2017 - 04.2018
Microbiology Laboratory Analyst I/II
Musculoskeletal Transplant Foundation
10.2013 - 06.2017
- Certified Quality Auditor (CQA) - American Society for Quality.
- ISO 9001: 2015 Quality Management Systems Internal Auditor Training - International Organization for Standardization.
- ISO 17024:2012 General Requirements for Bodies Operating Certification of Persons Training - International Organization for Standardization.
- Lean Six Sigma Green Belt Training - NEPIRC, Hanover Township, PA.
B.S. Biochemistry -
Moravian College
Similar Profiles
LAKSHMI NARAYANA VATTIKULLALAKSHMI NARAYANA VATTIKULLA
ROPE ACCESS NDT TECHNICIAN at Seacorr nondestructive testing services llcROPE ACCESS NDT TECHNICIAN at Seacorr nondestructive testing services llc
Ibrahim El NaggarIbrahim El Naggar
Finance Manager. at ASNT Co for Advanced Solutions Network TechnologyFinance Manager. at ASNT Co for Advanced Solutions Network Technology
HARINI ELANGOVANHARINI ELANGOVAN
BDM and Administrative Assistant at ASNT Pvt LtdBDM and Administrative Assistant at ASNT Pvt Ltd