Quality Engineer Assistant

Lisa P. Rudd, RN, BSN, BS/MS

**** ******** ***** ************, ***** Carolina 27284

336-***-**** – Home 336-***-**** – Mobile ******@*****.***

Documentation Specialist/ Medical & Scientific Writer

ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA)

ASQ Manager of Quality Organizational Excellence (CMQ/OE)

ASQ Certified Software Quality Engineer (CSQE), ASQ Six Sigma Green Belt (CSSGB), ASQ Certified Supplier Quality Professional (CSQP), ASQ Certified Quality Process Analyst (CQPA), ASQ Certified Quality Improvement Associate (CQIA), ASQ Certified Calibration Technician (CCT), ASQ Certified Quality Inspector (CQI), Certified HACCP Auditor (CHA), ASQ Certified Quality Technician (CQT), PMI Certified Associate in Project Management (CAPM )

Lisa executed a number of assay optimization studies while at Chemring. She was able to operate independently and execute the test plan that we would collaboratively develop. She effectively managed her time and deliver data to help move the project forward. She was willing to learn new techniques on her own and then apply them to our test program.

Eric Lynch, Experienced Product Development Lead in Instrumentation and Sensing, Chemring Detection Systems

I worked with Lisa at PharmaCore in a very fast-paced, analytical lab. Lisa was a very hard worker and always willing to take on extra tasks.

Amanda Flanagan, Director at PharmaCore

Lisa was very helpful in providing support to analysis of our resin project here. She has been able to give timely results to different specimens that have been submitted and used the right technique to achieve that.

Haibo Li, Chemist, Ennis Traffic Safety Solutions

While providing IT support for the R&D group, I found Lisa to be knowledgeable and extremely helpful when identifying systems or applications that required my services. I could always count on her to be detailed, articulating specifically what assistance was needed. I would gladly work alongside her in future.

Beilo W., IT Support Specialist, Ennis Traffic Safety Solutions

SUMMARY OF EXPERTISE

Quality Management/ Project Management: ISO-9001, 7 classic quality tools, process improvement (DMAIC, root cause analysis, SIPOC, PDCA/PDSA), Statistical Process Control, MiniTab, SPSS, JMP

Analytical strengths: Analytical method development and validation experience: HPLC-DAD, GC,

GC-MS, and pyrolysis-GC/MS. Thermal analysis/physical characterization: TGA, DSC, XRPD, particle

size analysis, weathering (QUV), analytical testing of reactive monomer in paint formulations.

Analytical method development/validation: (HPLC, HPLC-MS, HPLC-MS-MS, GC, GC-MS, XRPD

Culture and maintenance of multiple cell types (mammalian), PCR, RT-PCR, ELISA/immunoassay,

DNA extraction, cloning, restriction enzyme digests, transfections, SDS-PAGE, Western blots, agarose

gel electrophoresis. Development of novel expression vectors and host cell lines, protein expression, purification, FPLC, enzyme assays, molecular/cellular based assays, cytotoxicity assays, and histology.

Pharmaceutical industry experience: Boehringer Ingelheim, Glaxo Wellcome, Inc. (GSK), and Targacept,

Inc. including experience and working knowledge of GMP and GLP guidelines. Analytical testing of raw materials, intermediates, and finished goods at Sigma Aldrich Inc.

Experience with HPLC (Agilent 1200/1100 series) Binary SL Pump, Quaternary Pump with DAD/VWD, Waters systems: 717 Series and Alliance 2695 Separation Module. GC (Agilent 6890, 5890, 5880 systems with a variety of detectors (FID, FPD, EC, MS), Schimadzu GC-2010 FID, and Perkin Elmer Clarus 500 GC-MS.

Scientific Software: Empower v.3 and v.2, HP ChemStation (GC/HPLC), Open Lab, Millenium 3.2 (HPLC), Lab Solutions (GC) EZChrom (GC), Metrohm-Peak software (IC), Micromass (LC-MS/GC-MS), LIMS.

Sample preparation: ASE (accelerated solvent extraction), solid phase extractions, SPME (solid-phase micro-extraction), capillary electrophoresis (CE), Ion Chromatography, KF titrations (coulometric and volumetric), disintegration testing, extraction techniques (ASE and SPE). Resolved sample matrix interference issues.

Lisa P. Rudd Page 2

PROFESSIONAL EXPERIENCE

June 2017 NOVANT MEDICAL CENTER/ CONE HEALTH ~ Winston-Salem/Greensboro, NC

to current Staff Nurse: Medical-Surgical, Progressive Care, Intensive Care

Nursing care provided for patients with rehabilitation needs following acute stroke, brain and/or spinal cord injury, orthopedic condition/surgery, and amputations.

Nursing care provided for critical care patients with acute respiratory failure, sepsis, post-surgical assessment and monitoring of hemodynamic status.

Nurse caring for patients undergoing treatment for renal failure as a primary diagnosis or secondary to hypertension and/or diabetes.

Chemotherapy administration, blood administration, patient assessment, medication administration, and nursing procedures as per physician orders.

August 2014 CHEMRING DETECTION SYSTEMS, INC. ~ Charlotte, NC

to August 2015 R & D Scientist / Biochemist

Performed PCR and Immunoassay experiments: assay development and optimization of an automated assay system for use in field by military personnel; assay of lyophilized reagents for immunoassay experiments/determination of storage stability.

Designed scripts to program operation of PCR/immunoassay in cartridge unit with reagents introduced by microfluidics.

July 2015 to BIOTA DIAGNOSTICS, LLC ~ Charlotte, NC

August 2015 GC-MS Chemist

Implemented environmental testing of volatile and semi-volatile organic compounds based on EPA Methods 8260 and 8270 using automated purge and trap (Teledyne Tekmar) coupled to Perkin Elmer Clarus 680 GC-MS.

March 2015 BASF ~ Charlotte, NC

to May 2015 R & D Technician

Performed latex-based paint formulations for traffic paint including preparing various paint formulations and testing physical properties including storage stability, dry time, and physical properties. Implemented pH-viscosity curves for latexes using in-paint formulations, adhesion testing and ASTM D711 testing.

May 2014 to PHARMACORE ~ High Point, NC

August 2014 Research Associate, GMP Analytical Chemistry

Executed complete HPLC method validations for third party client in contract research (CRO) setting. Demonstrated system suitability, system precision, specificity, linearity/range assay and impurities, LOD, LOQ, accuracy, recovery, precision and solution stability (samples and standards). Completed validation reports for client; performed data acquisition (Agilent 1200/ChemStation).

June 2013 ENNIS FLINT – TRAFFIC PAINT ~ Thomasville, NC

to May 2014 R & D Chemist

Performed polymer characterization by standard analytical methods to support in-house paint formulations lab; included new product formulations, competitive samples; field failure analysis on epoxy resins, hard resins, and latex-based paints using GC-FID, GC-MS, size-exclusion chromatography (SEC), thermal analysis by TGA and DSC, FTIR, XRF, and tensile strength testing. De-formulation of competitive epoxy-resins.

Developed and validated DLS and Zeta potential analysis, specific for latex seed and final pilot batches. ASTM test method analysis of epoxy-equivalent value, amine value, and volume solids; Brookfield viscosity, tensile strength.

Lisa P. Rudd Page 3

PROFESSIONAL EXPERIENCE – SCIENTIFIC and MEDICAL (continued)

April 2012 BOEHRINGER INGELHEIM, INC. ~ Columbus, OH

to May 2012 Scientist II – Quality Control

Analytical testing of non-solid pharmaceutical products including bulk, release, and stability lots under GMP and GLP guidelines. Prepared standards and samples for analysis under established methods; performed testing by HPLC with Empower 2 data acquisition and analysis software, pH, density, UV/Vis. Transferred and received project work between team members to achieve goals and target timelines.

January 2011 to WINSTON-SALEM STATE UNIVERSITY ~ Winston-Salem, NC

December 2011 Research Lab Technician

Performed in vitro antimicrobial activity assays on novel cyclic peptides with antibiotic properties as adjuncts to existing antibiotics. Testing of MIC (minimum inhibitory concentration) and synergy with traditional antibiotics was performed using E. Coli Gram and S. Aureus Gram bacterial systems.

May 2011 to SIGMA-ALDRICH CORPORATION ~ St. Louis, MO

August 2011 Analytical Development / SAFC Intern – Process Development Group

Transferred analytical methods for analysis of raw materials from Analytical Sciences (ISO 9001) to GMP Quality Control; ensured that methods used for raw materials testing was reproducible by establishing appropriate system suitability (%RSD, resolution) criteria. Analytical development reports and SOPs were written for transferred methods.

August 2010 to May FORSYTH TECHNICAL COMMUNTY COLLEGE ~ Winston-Salem, NC

2011 and August 2008 Science / Math Tutor (8/10 to 5/11)

Professional tutor, individual and group tutoring: undergraduate biology, chemistry, and math.

Adjunct Instructor (8/08 to 5/09)

Instructor for undergraduate General and Analytical Chemistry; prepared and managed all course material.

August 2010 to ROWAN-CABARRUS COMMUNITY COLLEGE ~ Salisbury, NC

December 2010 Adjunct Instructor

Instructor for undergraduate General and Analytical Chemistry; prepared and managed all course material.

May 2009 to WAKE FOREST REGENERATIVE MEDICINE ~ Winston-Salem, NC

August 2009 Laboratory Technician

Prepared pig liver extracellular matrix (ECM) based on established protocols; developed new decellularization protocols for use in drug screening. Supervised, mentored, and trained cooperative education student from FTCC in the AAS Biotechnology program.

Lisa P. Rudd Page 4

PROFESSIONAL EXPERIENCE – SCIENTIFIC and MEDICAL (continued)

August 2003 WAKE FOREST UNIVERSITY ~ Winston-Salem, NC

to May 2009 Graduate Student Research Assistant

Performed research in laboratory setting leading to one peer-reviewed publication and two scientific abstracts. Conducted independent experiments; prepared scientific data for meetings and presentations; daily lab management and maintenance. Served as Teaching Assistant (TA) for undergraduate labs.

August 2002 UNIVERSITY OF NORTH CAROLINA AT GREENSBORO ~ Greensboro, NC

to May 2003 Graduate Student Research Assistant

Performed research in laboratory setting leading to one peer-reviewed publication and two scientific abstracts. Conducted independent experiments; prepared scientific data for meetings and presentations; daily lab management and maintenance. Served as Teaching assistant (TA) for undergraduate labs.

October 2000 TARGACEPT, INC. ~ Winston-Salem, NC

to October 2002 Scientist II

Analyzed in-process and QA samples by GC-MS and LC-MS, Ion

Chromatography (IC) analysis of drug counter ions. IC and GC-MS instrument maintenance and troubleshooting. Maintained synthesized compounds structure/physical properties data in ISIS Base database. Synthesized pyridylquinuclidine intermediates/final compounds.

February 1998 R. J. REYNOLDS TOBACCO COMPANY ~ Winston-Salem, NC

to October 2000 Chemist I (2/98 to 10/00); Laboratory Technician (10/97 to 2/98)

Accountable for extraction, cleanup, and GC-FPD analysis of organophosphorus (OP) pesticide residues in tobacco. Cross-trained on herbicide pesticide analysis by GC-ECD.

Characterization of pyrazine flavor/aroma compounds produced from the reaction of sugar and ammonia by GC-MS and GC-FID; assessed variables of sugar/tobacco type, stalk position, and leaf development.

May 1996 to GLAXO WELLCOME, INC. ~ Research Triangle Park, NC

August 1997 Medicinal Chemistry Intern (5/97 to 8/97); Analytical Sciences Intern (5/96 to 8/96)

Research performed in organic chemistry lab for development of anti-diabetic drug candidate. Function included synthesis of anilines used in preparation of Beta3 receptor agonist analogs.

Performed solubility and drug recovery assays from tablet formulation; method development involving optimization of instrument parameters and mobile phase compositions; gained experience with analytical techniques including: HPLC, GC, IR, UV/VIS spectroscopy, and KF titrations.

Lisa P. Rudd Page 5

EDUCATION – University and College degrees/diplomas

University of North Carolina at Wilmington ~ Wilmington, NC

Bachelor of Science in Nursing (July 2018)

Forsyth Technical Community College ~ Winston-Salem, NC

Associates Degree Applied Science in Nursing

Wake Forest University ~ Winston-Salem, NC

Master of Science Degree in Biochemistry and Molecular Biology

Thesis: Comparison of redox-active and conjugative enzymes with and without efflux transporters and their comparative effectiveness in protection against cellular toxicity of 4-hydroxy-2-nonenal (HNE), an aldehyde lipid peroxidation product

University of North Carolina at Greensboro ~ Greensboro, NC

Master of Science Degree in Chemistry

Thesis: Analysis of commercial products by capillary zone electrophoresis and micellar

electrokinetic chromatography.

Bachelor of Science Degree in Chemistry – magna cum laude – ACS Certified Degree

Undergraduate Research Experience: Free radical DNA base pair damage in Koi carp.

Southwestern Community College, Sylva, NC~ graduation with honors

Associates Degree Applied Science (AAS) Web Technologies

Associates Degree Applied Science (AAS) Computer Information Systems

Certificate in Network Management (Cisco Certificate)

Certificate in Mobile Applications Development

Certificate in Operating Systems

Forsyth Technical Community College ~ Winston-Salem, NC

Business Administration – Customer Service Certificate

Southwestern Community College, Sylva, NC~ graduation with honors

Certificate in Accounting

EDUCATION – Continuing Education and non-degree academic

Coursera Data Science: Johns Hopkins Bloomberg School of Public Health

Five of 10 courses complete. A 10-course non-credit specialization authorized by Johns Hopkins University and offered through Coursera. Additional Coursera Courses in Clinical Research.

Exploratory Data Analysis Certification Date Oct 2015 – Present License Z55VJLY2NN

Getting and Cleaning Data Certification Date Oct 2015 – Present License QVR7SUCUAB

R Programming Certification Date Oct 2015 – Present License 4SQHRWX3H4

Regression Models Certification Date Oct 2015 – Present License HC3WSFQG63

The Data Scientist’s Toolbox Certification Date Oct 2015 – Present License 7NG2VQ3QCH

Design and Interpretation of Clinical Trials Certification Date Dec 2016 – Present License DFL9X2KG58E7

Introduction to Genomic Technologies Certification Date Oct 2015 – Present License FV4XQBYJVS

Programming for Everybody (Getting Started with Python) Oct 2015 – Present License SYEANDSC2VPW

Python Data Structures Certification Date Oct 2015 – Present License Z48FY8GXVNXW

SAS Institute: Certificate of Completion ~ e-Learning Courses

Statistics I: Introduction to ANOVA, Regression, and Logistic Regression

SAS(R) Programming 1: Essentials

Rockingham Community College ~ Wentworth, NC

Continuing Education Courses: Project Management Fundamentals ... Project Management

Applications ...Six Sigma Total Quality Fundamentals / Applications

Lisa P. Rudd Page 6

PUBLICATIONS

Rudd, Lisa. (July 14, 2018). [letter to the editor]. Painter, S.G., (May 31, 2017) "Opiate Crisis and Healthcare Reform in America: A Review for Nurses" OJIN: The Online Journal of Issues in Nursing Vol. 22, No. 2, Manuscript 3.

Jenna Dumond, Lisa Rudd, Jean-Herbert Rigaud, Maria Ngu-Schwemlein, PhD, In vitro synergy between some cationic amphipathiccyclooctapeptides and antibiotics. (2014) Australian Journal of Chemistry.

Lisa P. Rudd, S. L. Kabler, C.S. Morrow, and A.J. Townsend, Ph.D., Enhanced glutathione depletion, protein adduct formation, and cytotoxicity following exposure to 4-hydroxy-2-nonenal (HNE) in cells expressing human multidrug resistance protein-1 (MRP1) together with human glutathione S-transferase-M1 (GSTM1). (2011) Chemico-Biological Interactions 194, 113–119.

Lisa P. Rudd, M. Aneskievich, R. Attaway, L. McDermott, A. Knecht “GMP Raw Material Analytical Method Transfer to Quality Control” Poster summarizing work completed at Sigma-Aldrich, Inc. for method validation and transfer of analytical methods for solvents, fatty acids, sugars, reducing agents, enzymes, and nucleotides.

Lisa Rudd, Adrian B. Rudd, Tarshona Stevens, Maria Ngu-Schwemlein, Ph.D., Winston-Salem State University, Chemistry Department, Winston-Salem, NC 27110. “Enhancing in-vitro antimicrobial activity of some antibiotics with cyclopeptide.” 242nd ACS National Meeting, August \28-September 1, 2011, Denver, CO

S. Ahmad, S. Leone-Kabler, L. Rudd, S. Amin, J. Doehmer, and A.J. Townsend, Ph.D., Cytotoxicity and mutagenicity of 5-methylchrydene and its 1, 2-dihydrodiol in V79MZ cells modified to express human CYP1A1 or CYP1B1, in the presence or absence of human GSTP1 coexpression. (2008) Toxicol Lett 183, 99-104.

Sarfaraz Ahmad, Sandra Leone-Kabler, Lisa Rudd, Johannes Doehmer, Alan J. Townsend, Ph.D., Wake Forest University Medical Center, Winston-Salem, NC, GenPharm Toxicology, Munich, Germany. Cytotoxicity and mutagenicity of 5-Methylchrysene in V79MZ cells stably transfected with human CYP1B1 or CYP1A1 and/or human GSTpi. Abstract 5242, AACR (American Association for Cancer Research), 97th Annual Meeting, April 1-5, 2006, Washington, DC

S. Ahmad, S. Leone-Kabler, L. Rudd, and A.J. Townsend, Ph. D., Wake Forest University School of Medicine, Biochemistry Department, Winston-Salem, NC 27157. Cytotoxicity and mutagenicity of 5-Methylchrysene and its dihydrodiol metabolite in V79MZ cells stably transfected with human CYP1B1 and/or human GSTPi/Mu. Abstract P7, Genetics and Environmental Mutagenesis Society, 23rd Annual Fall Meeting, October 26, 2005, UNC Friday Center, Chapel Hill, NC

ACHIEVEMENTS, HONORS & AWARDS:

Marquis Whos’ Who® Biographical Listee, Top 3 % of Professionals in the World (2018)

Current Member of American Mensa®, Top 98th Percentile Intelligence (2009-current)

Nu Omega Chapter of the Honor Society of Nursing, Sigma Theta Tau International (STTI)

oUniversity of North Carolina at Wilmington, Inducted Spring 2018

Baldwin Scholarship (2016: NCBSN Learning Extension NCLEX course); Auxiliary of Forsyth Medical Center (2015-2016 academic year); Lettie Pate Whitehead Scholarship (2014-2015 academic year)

Member of Southwestern Community College Chapter (NTHS) National Technical Honor Society (2015)

Member of Phi Theta Kappa honorary society at Central Piedmont Community College (2015)

R.J. Reynolds Tobacco Co. Analytical Chemistry Division Award (1999)

Member of the Phi Beta Kappa honorary society (1996)

Sherri R. Forester Undergraduate Chemistry Award University of North Carolina at Greensboro (1996)

UNCG Century Scholar for Incoming Freshman (1993)

Girl Scout Silver Award (1992)

to May 2009

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