Lisa Gillett
Fairmont,WV
Summary
PHARMACEUTICAL QUALITY SPECIALIST Dedicated Quality Assurance Specialist with demonstrated Quality Control, Research & Development, and Manufacturing experience in the pharmaceutical industry. Background in root cause analysis, CAPAs, and National Science Foundation certified in Investigations. Keen ability to ensure quality policies are met and procedures followed per approved Standard Operating Procedures.
Overview
16
16
years of professional experience
Work History
GMP Investigation Specialist (Consultant)
Eurofins PSS Insourcing Solutions, LLC
Rensselaer, NY
05.2022 - Current
- Independently investigating deviations in support of Quality Control Operations and Technical Services
- Collaborated with cross-functional teams to facilitate investigation process
- Engaged all critical stakeholders of deviation to determine most appropriate solution to problem path forward
- Promoted right-first-time culture and ensured closure of deviations promptly
- Prepared investigation reports and recommendations on investigation findings for low/medium severity deviations
- Documented deviations using ProcessCompliance following current good manufacturing practices (cGMP) in compliance with FDA regulations.
Technical Specialist
Novavax, Inc
Gaithersburg, MD
10.2021 - 05.2022
- Served as Quality Control SME on cross-functional special project team
- Acted as Quality Control record owner of subset of quality records, including Deviation, CAPA, OOS, and Change Control
- Drove quality records to successful closure in partnership with cross-functional SMEs and Records Owners (QA, QC, Process Development, MS&T)
- Led and supported continuing improvements of manufacturing processes to enhance efficiency and compliance
- Provided technical support of GMP QC Operations and staff, including authoring, revising, and reviewing GMP supporting documentation.
- Enhanced and reconstructed computer systems to increase efficiency.
Quality Assurance Investigation Specialist
Viatris, Mylan Pharmaceuticals, Inc
Morgantown, WV
02.2019 - 07.2021
- Quality Investigations
- Conducted quality review of all levels of manufacturing incidents and investigations
- Identified potential areas of compliance vulnerability and risk to develop and implement corrective action plans
- Selected for project to assist with review and closure of Quality Manufacturing Investigations backlog
- Completed 225+ investigations to help site reach stable state of total open investigations and reducing backlog of investigations by 96%
- Reviewed investigational reports in order to ensure that appropriate steps had been taken throughout investigation and that all information regarding investigation were accurately and correctly documented
- Coordinated and led meetings dealing with Investigations, CAPAs or process improvement strategies during course and closure of investigation reports
- Trained on manufacturing and packaging equipment used in production of Solid Oral Dosage Units
- Trained in effective CAPA plans to respond to deviations and compliance violations.
Chemist
Mylan Pharmaceuticals, Inc
Morgantown, WV
07.2018 - 02.2019
- Quality Control
- Conducted composite Assay, Content Uniformity, Dissolution, and Related Compounds testing Finished Product utilizing HPLC
- Identified and investigated aberrant and atypical data according to laboratory SOPs utilizing Trackwise
- Audited technical data for experimental stability monitoring to ensure compliance with laboratory SOPs and other regulatory guidelines
- Experienced with USP regulations, cGMPs, GDP, site SOPs, and Quality Control Laboratory Procedures.
Chemist
Mylan Pharmaceuticals, Inc, Quality Technical Services
Morgantown, WV
05.2015 - 07.2018
- Selected as team member for support of analytical method and protocol transfers between Research and Development and Quality Control Laboratories
- Conducted composite Assay, Content Uniformity, Dissolution, and Related Compounds testing of Raw Materials, Intermediates, and Finished Product utilizing HPLC, UPLS, and UV-Vis techniques in support of method transfers
- Identified and investigated aberrant and atypical data according to laboratory SOPs utilizing Trackwise
- Audited technical data for Research and Development and Quality Control Departments, including that for experimental method development, method validation, and stability monitoring to ensure compliance with laboratory SOPs and other regulatory guidelines
- Trained as author and reviewer for SOPs, procedures, and protocols in Documentum Compliance Manager Software.
Adjunct Laboratory Instructor
Fairmont State University
Fairmont, WV
08.2013 - 08.2017
- Taught General Chemistry, Instrumental Methods, and Advanced Inorganic Laboratories
- Supervised lab groups of 15-20 students during experiments
- Maintained safe laboratory environment during lab course work
- Graded quizzes, tests, homework, and projects to provide students with timely academic progress information and feedback
- Conducted engaging in-class discussions to facilitate learning and encourage participation
- Built strong rapport with students through class discussions and academic advisement.
Chemist
Mylan Pharmaceuticals, Inc
Morgantown, WV
12.2012 - 05.2015
- Research and Development
- Provided analytical support for testing of drug substances, intermediates, and drug products for initial release and stability monitoring
- Trained in HPLC (UV, RI, PDA, and Conductivity Detectors), UPLC, Dissolution Apparatuses (App 1-7), UV Spectroscopy, other physical and chemical testing, LIMS, Trackwise, and Empower
- Experienced in authorizing and auditing documentation for testing, regulatory review, and submission of pharmaceutical products, including data summaries, analytical procedures, protocols, reports, and COAs
- Investigated aberrant and atypical data according to laboratory SOPs through use of computerized system to manage laboratory investigations
- Served as New Employee Trainer for use of HPLC, UV-Vis, and general laboratory techniques in accordance with laboratory SOPs
- Served as Summer Internship Program Advisor and Mentor
- Supervised chemistry Interns in laboratory and conducted weekly mentoring meetings with Interns across multiple departments
- Maintained regulatory compliance for all projects.
Chemistry Intern
Mylan Pharmaceuticals, Inc
Morgantown, WV
05.2012 - 12.2012
- Research and Development
- Engaged in research activities to develop analytical methods to determine t viability of analytical column and developed methods for column cleaning and restoration
- Performed laboratory equipment daily verification, calibration of balances and pH meters
- Assisted with bulk sample preparations in team setting where cooperative effort was required to complete ssigned workload.
Program Specialist
West Virginia University, Academy, HSTA
Morgantown, WV
01.2008 - 10.2012
- Recruited diverse group of 8th grade students into HSTA program and monitored their success through college
- Supervised staff of 6 instructors and 60 students
- Created and implemented curriculum for teachers and high school students with STEM and multicultural focuses Assessed and reported on annual goals and objectives fusing data collected from us of formative, summative, and benchmark assessments
- Served on Summer Advisory Board and worked to continuously assess programs’ effectiveness and improve program quality by seeking new strategies and responding to feedback on ongoing basis
- Planned and coordinated annual events including informational meetings, awards ceremonies, and trainings for regional students, teachers, board members, and parents
- Wrote, designed, and distributed promotional materials.
Education
Six Sigma Green Belt, ASQ -
December 2021
Six Sigma Yellow Belt, ASQ - undefined
July 2021
Fundamentals of Biopharmaceutical Manufacturing - undefined
NC State University
June 2021
Six Sigma White Belt, Viatris - undefined
March 2021
Advanced Microsoft Excel, Pryor Learning Solutions - undefined
October 2020
Project Management Workshop, Pryor Learning Solutions - undefined
October 2020
Microsoft Excel Beyond the Basics, Pryor Learning Solutions - undefined
August 2020
DEVELOPMENT - undefined
October 2019
Bachelor of Science - Chemistry
Fairmont State University
Bachelor of Arts - Political Science
West Virginia University
Master of Public Administration - undefined
West Virginia University
Skills
- Problem Resolution Team Development Communication Project Management Problem-solving
- Compliance Management Data Analysis Process Improvement Auditing Root Cause Analysis
- Word, PowerPoint, Excel, Access, Outlook, Teams, Trackwise, SAP, Tableau
- Analytical and Critical Thinking
Timeline
GMP Investigation Specialist (Consultant)
Eurofins PSS Insourcing Solutions, LLC
05.2022 - Current
Technical Specialist
Novavax, Inc
10.2021 - 05.2022
Quality Assurance Investigation Specialist
Viatris, Mylan Pharmaceuticals, Inc
02.2019 - 07.2021
Chemist
Mylan Pharmaceuticals, Inc
07.2018 - 02.2019
Chemist
Mylan Pharmaceuticals, Inc, Quality Technical Services
05.2015 - 07.2018
Adjunct Laboratory Instructor
Fairmont State University
08.2013 - 08.2017
Chemist
Mylan Pharmaceuticals, Inc
12.2012 - 05.2015
Chemistry Intern
Mylan Pharmaceuticals, Inc
05.2012 - 12.2012
Program Specialist
West Virginia University, Academy, HSTA
01.2008 - 10.2012
Six Sigma Green Belt, ASQ -
Six Sigma Yellow Belt, ASQ - undefined
Fundamentals of Biopharmaceutical Manufacturing - undefined
NC State University
Six Sigma White Belt, Viatris - undefined
Advanced Microsoft Excel, Pryor Learning Solutions - undefined
Project Management Workshop, Pryor Learning Solutions - undefined
Microsoft Excel Beyond the Basics, Pryor Learning Solutions - undefined
DEVELOPMENT - undefined
Bachelor of Science - Chemistry
Fairmont State University
Bachelor of Arts - Political Science
West Virginia University
Master of Public Administration - undefined
West Virginia University
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