Curriculum Vitae

EDUCATION

 

Masters of Engineering: Industrial Engineering                    

 University of Louisville                       December 2008            Louisville, KY

                                                                                                                             

Bachelors of Science: Industrial Engineering

University of Louisville                         December 2007            Louisville, KY  

                                                                                                                          

Bachelors of Science: Chemistry, minor Biology

University of Louisville                         December 1998            Louisville, KY

  

Certification:  BSI AS9100C Lead Auditor                                                      

                                                                  December, 2015

 

Certificate:  BSI AS9100D Auditor Training    July 2017                                                                                                                  

 

Certification:  IPC -  J-STD-001 (Electrical Assembly Certification)                                                                                                     November, 2015

 

 

SKILLS

 

 Quality Auditing           Statistical Process Control         GLP, GMP, CAPA,         Trackwise,       Protocol Writing           Change Control,                         HACCP,  SQF,                IQ, OQ, PQ     Regulatory Affairs        Quality Management System      Document Control,        FMEA,

 SOP, SOW                    Quality Training                          GC/MS/UV/IR/LC,       MS Office   Minitab SAP                 Problem Solving                         Research                         ISO 9001         SharePoint                    Teaching                                      Cold Supply Chain         CRF 211                                               Operations Management

                                                  

                                                                                           

 

AFFILIATIONS

 

SWE/Society of Women Engineers                 ASQ/American Society for Quality

IIE/ Institute of Industrial Engineers                Golden Key International Honor Society

 

 

 

 

 

ENGINEERING EXPERIENCE – AEROSPACE / PHARMACEUTICAL

 

Davis Aircraft Products– Bohemia, NY   March 2018 to Present 

 

Quality Engineer (Aerospace)

  • Lead Auditor in the implementaion of the AS9100 revision D Quality Management System. 
  • Investigate, determine, and implement RCCA, supporting CAPA, and continuous improvement activities.

 

 

GE Aviation / Bentley Global Resources – Long Island, NY   November 2017 to March 2018 

 

Quality Engineer (Aviation) – contract position

  • Quality Assurance: Supported the implementation of AS9100 revision D (AS9100 revision C) Quality Management System
  • Quality Compliance: Government source inspector for final inspection of electrical assemblies.
  • Implement process improvements to eliminate reoccurence of quality findings. 

 

 

Adient / Aerotek – Georgetown, KY   September 2017 to November 2017 

 

PPAP Quality Engineer (Automobile) – contract position

  • Responsible for reading and interpreting blueprints, documentation, engineering specifications and GD&T
  • Proficient in completing and understanding APQP, PPAP, PFMEA, Control Plans and 8D Corrective Actions.
  • Represent quality in the Product Launch Team while ensuring both customer an internal requirements are met. 
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Cobham Mission Systems / American Contract Group (Aerospace) - Davenport, IA   March 2017 to September 2017  

 

Contract Review Analyst / Senior Compliance Quality Engineer -contract position

  • Lead quality contact review for customer contracts; ensured organization was meeting customer requirements and compliance with government regulations. Responsible for providing technical input on quality and contractual issues to internal stakeholders for external customers.
  • Served as Quality Representative on Integrated Product Teams and on corrective action teams
  • Analyzed production and service limitations; recommend revisions of specifications when indicated.
  • Responsible assisting in the update and implementation of quality assurance policies and procedures.  Compiled and performed various reports and audits.
  • Responsible for the development and modification of procedural documents. Assisted with the implementation of quality standards and regulatory requirements.
  • Conduct training on quality assurance concepts and tools; interpreted engineering drawings and specifications

 

 

 

Topy America (Automotive)  Frankfort, KY                    November 2016 to February 2017

 

Customer Quality Engineer

•Assured products conformed to company requirements and standards through audits; worked with external customers at the launch of new programs in carrying out specific requirements as related to product.

•Performed inspection reports, GD&T, and test activities. Interacted with internal departments at all levels and external customers and suppliers.

•Responsible for formulating procedures, specifications, and standards for products and processes following customer and company requirements with consideration to ISO/TS 16949:2009. Established communication links with customers, vendors, and internal departments.

•Successfully conducted root cause analysis of quality problems; developed and implemented corrective counter measures using 5P, 5 Why and 8D formats. Provided daily instruction, guidance, and assistance to quality inspectors as it related to their job function.

•Performed necessary PPAP’s and provided the necessary support to APQP activities, established inspection procedures, designs, and procured inspection gauges; responsible for conducting gauge reliability studies, and created calibration, inspection, and test standards and forms.

•Liaison to customer PQE’s and other quality representation for new product development and existing programs. Responsible for conducting internal and external supplier audits to requirements of ISO/TS16949:2009

 

 

Wichita State University – Wichita, KS                      August 2016 to November 2016 

         

Doctoral Graduate Teaching Assistant / Industrial Engineering

  • Teaching Assistant for undergraduate Engineering Probability and Statistics
 

 

Northrop Grumman (Aerospace & Defense) – San Diego, CA  August 2015 to August 2016 

 

Quality Engineer  / AS9100 C Lead Auditor

  • Responsible for working within integrated teams to analyze, control and improve product quality; assured clear identification, physical control and competent disposition of non-conformances
  • Facilitated corrective actions, closed loop process controls and continuous improvement methods to improve product/process predictability and capability; managed the interface and sell-off of products to downstream operations or end item customer quality representatives
  • Successfully performed floor audits of production processes and procedures; Evaluated manufacturing processes for compliance with quality requirements. 
  • Successful at identifying processes where the organization is meeting the requirements as well as identifying opportunities for improvement.
  • Managed and directed weekly internal audit functions to ensure company policies, procedures, and internal controls were designed and functioning to accomplish organizational goals effectively and efficiently; identified risks, control gaps, recommendations, and possible corrective actions, ensuring issues and observations were communicated before audit results are finalized and formally distributed.
  • Prepared detailed reports on audit findings and worked with managers and staff to resolve non-conformances and deficiencies; worked hands on with staff auditors, providing guidance in audit techniques, risk assessments, and audit report writing. Assisted in the development of internal and external audit plans and audit schedules; worked directly with external auditors in successful renewal of company certification
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Ben Venue Labs (Pharmaceutical) – Bedford, OH      February 2012 to August 2012   

       

Validation Engineer

  • Responsible for facilitating execution of validation studies per approved protocols
  • Analyzed test data and prepared technical reports
  • Responsible for leading execution of validation activities performed by production operators
  • prepared test equipment and components in the execution of validation activities, and facilitated execution of IQ, OQ, PQ.
  • Supported execution and coordination of activities related to CAPAs and special projects
  • Responsible for developing protocols, reports, and procedures
  • Responsible for Applying principles of Current Good Manufacturing Practices (cGMPs) Interfaced with Engineering, MST, and Production to troubleshoot existing products and support new product transfer requirements.       

                                                                                       

 

 

QUALITY EXPERIENCE – PHARMACEUTICAL/ FOOD/ SUPPLY CHAIN

 

Kaztronix / Novartis (Cold Supply Chain) – Louisville, KY       February 2015 to July 2015

Quality Specialist – Contract Position

 

  • Successfully managed the review and approval of transportation data; product returns, withdraws and recalls to ensure third-party distributors perform thier services within teh scope of the quality agreement. 
  • Participated in distributor complaince audits and quality risk assesment of distributors 
  • Collaborated with third-party distributors and various V&D quality groups to approve V&D product specific work insturctions and SOPs. 
  • Tracked CAPA/remediation plans and ensured the progres; collaborated with Global GMP complaince to ensure progress of audit CAPAs and provided support of cold chain transportation validation. 
  •  Provided local disposition of vaccine products at distributor location in coordination with various NVD site quality organizations; worked with third party quality functions to ensure appropriate V&D specific training modules are developed and training performjed. 
  • Participated in investigations pertaining to distribution excursions and/or deviation in collaboration with NVD quality units. 
  • PIP available to immediately traige quality issues at they occured and facilitaed communication flow between contractors at various V&D manufacturing sites and global quality operations. 

 

 

SCA Pharmaceuticals – Little Rock, AR                       August 2014 to November 2014 

 

 Quality Assurance Analyst

  • Successful in working in fast paced environments; good writing, verbal, decision making and Organizational/ interpersonal skills. Developed complete working knowledge of cGMPs; ensured all controlled documents and records met CGMP and ISO requirements
  • Provided a high level of understanding of relevant production processes and quality systems. Assisted Quality Manager in updates and improvements to the Quality Management Systems that support QA through the development and implementation of QMS; such as, Change Control, CAPA, Document Control and training staff on GMP and related task. 
  • Conducted, reviewed, and updated, Quality Investigations (Deviations, Product Complaints) Validation Plans, Protocols, Audits, Reports and Standard Operating Procedures
  • Worked directly with staff in coordinating FDA readiness.  Responsible for tracking documents during the routing, review and approval process; maintained master documents; track and close Change Controls and SOP/Form Change Requests.
  • Designed, reviewed and revised SOPs, policies, forms and controlled documentation for appropriate format, content and consistency.  Issued, reviewed, and approved master batch records, labels, and other production documents in compliance with the requirements of the Customer and FDA.
  • Managed and implemented label process, reconciliation, and sampling plan in accordance with FDA guidelines; used FMEA to make recommendation for continuous improvement and assisted in providing guidance with strategies.
  • Responsible for calibration program; managing, revising, and implementing; equipment, instruments, and maintenance; logs, SOP’s and log books. 
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ConAgra (Food Manufacturing) – Louisville, KY       April 2014 to July 2014                       

Quality Assurance Technician – Contract Position

  • Responsible for periodic audits of plant and product quality, GMPs, QA practices, etc.; worked with production in identifying root cause of defect trends. Assists Quality Assurance Manager in solving and rectifying plant and product quality issues; performed incident investigations by collecting and reviewing information and generation of reports.
  • Involved in Allergen control and hygienic restoration programs to ensure effectiveness and implementation; responsible for daily HACCP reviews; analyzed reports for accuracy, completeness, and compliance with specifications and food safety regulations prior to releasing products to warehouse for shipment to customers.  Required to stop production lines if needed to rectify quality issues.
  • Routinely observed production activities to assure consistency and conformance to standards, as well as providing improvement suggestion
  • Worked directly with QA hold management; responsible for deciding if an item should be placed on hold and use decision making skills to conclude if process/product is within specification and can continue operations; responsible for accepting / rejecting decisions on finished product blends based on company / customer specifications.
  • Performed attribute tests on both raw and finished product:  color, texture, size, defect, flavor, and foreign material evaluation; analyzed incoming ingredients in accordance with approved test methods, in process finished products, and R&D samples for specifications.  Responsible for reporting of, and investigation of, defect issues that occur during manufacture such as foreign material contamination.

 

 

JLM Pharmatec (Pharmaceutical) – Seymour, IN      August 2013 to November 2013

 

 Quality Assurance Technician – Contract Position

  • Managed and sampled in-process production and incoming raw materials; oversight of stability program, reserve samples, inspection of manufacturing components and finished product.
  • Responsible for Quality Control Laboratory, laboratory methods, procedures, laboratory-controlled documents, SOPs, record retention, RO water system, safety procedures, and GMPs.
  • Analyzed lab results and compared results to acceptable limits on a timely basis to meet production demands for on-time shipments.
  • Assisted in the issuing of batch records and final Release for Shipment of finished products. Managed and approved the release of all components to production, batch start up and in-process checks, filing, and document retention.
  • Responsible for performing all Quality responsibilities in full compliance with SOP’s, FDA and cGMP’s.
  • Maintained and controlled all laboratory documentation required to prove the quality strength, purity, and identity of all manufacturing and packaging components and finished products.
  • Assist with the release of GMP components, labels, starting materials, intermediates, Drug Substance and Drug Product, to include data review and applying quality status tags.

 

 

 Pharmco-AAPER (Chemical) – Shelbyville, KY        June 2009 to October 2009

                                                                                                                       

Senior Quality Control Chemist

  • Managed and performed chemical analysis and quality control procedures on ethanol related products. 
  • Quality equipment: GC/MS, UV, IR, Density Meter, Karl Fisher

 

 

 

CLINICAL RESEARCH / REGULATORY EXPERIENCE

 

University Hospitals – Cleveland, OH                               June 2011 to November 2011

 

Regulatory Analyst / Clinical Trials Coordinator

  • Worked directly with the assigned team of physicians, research nurses and data managers to ensure that research is conducted in compliance with local, state, and federal regulations. 
  • Independently prepared and managed all regulatory submissions within the appropriate time frame for assigned research studies such that all research studies are reviewed by appropriate oversight committees.
  • Responsible for writing local patient consent forms, assent forms, and information sheets according to study sponsor guidelines, and local IRB conventions and policies.
  • Negotiated disagreements upon consent form language with sponsor. 
  • Gathered study-related data and synthesized it into annual reports of study activity for submission to local oversight committees as well as the Food and Drug Administration (FDA). Prepared FDA submissions for internally-sponsored Investigational New Drug (INDs) applications.

   

 

University of Louisville (Research) – Louisville, KY   November 2001 to May 2002

 

Research Sleep Coordinator

  • Managed, coordinated, and conducted various research sleep projects. 
  • Served as principal coordinator of infant sleep research; facilitated scheduling of appointments, follow-up visits, and working with vendors in ordering sleep equipment, including summary assessments when needed.
  • Assisted in the planning, implementation and evaluation of project components. 

                                                                                                  

 

The Scripps Research Institute – San Diego, CA         September 1999 to August 2000

                                                                                                

Clinical Research Sleep Coordinator

  • Coordinate research for a Study of the Genetics of the CNS based sleep disorder, Narcolepsy.
  • Interpret research protocols and coordinate task related to protocols, data collection, and data analysis to assure compliance and completion. 
  • Under the supervision of project physician and the Principal Investigator, screen subjects, scheduled Sleep laboratory and clinical laboratory studies
  • Demonstrated knowledge of the clinical research setting, protocols, principles, and standards
  • Managed patient Databases

                                                                                                      

 

 

University of California San Diego – San Diego, CA   September 1999 to July 2000

 

Clinical Research Sleep Coordinator

  • Successfully interacted with research team. Educated performed and evaluated patients identified or treatments in the clinical sleep disorder-breathing program.
  • Assisted in the management CPAP trails. Performed sleep test, CPAP titration and CPAP trials
  • Collected and analyzed sleep data. Demonstrated experience in clinical research trials, direct patient care and protocol implementation.

 

 

 

LABORATORY / HEALTH CARE EXPERIENCE

                                     

Parallel Products – Louisville, KY                                              July 2007 to February 2008

 

Laboratory Technician

  • Performed quality testing on inbound and outbound shipments for solid content and alcohol percentages. 
  • Adjust, maintain, and performed minor repairs and reports of all laboratory equipment.
  • Calibrated and cleaned all laboratory equipment per the manufacturer’s recommendations per Standard Operating Procedures. Quality equipment: GC/MS, UV, IR, Density Meter, Karl Fisher.

 

 

                                                                                                     

University of Louisville Hospitals – Louisville, KY                 July 2007 to January 2008

                     

Phlebotomist / Clinical laboratory Assistant

  • Collected blood specimens from patients throughout the facility. 
  • Demonstrated thorough knowledge of specimen processing, clerical, and computer documentation.
  • Assisted the technical coordinator in assuring compliance with medical necessity.

 

 

 

Brown Foreman (Distillery) – Louisville, KY              March 1997 to March 1999

                   

Laboratory Technician – Coop (Chemical Engineering)

  • Developed and analyzed new products, 
  • Performed analytical testing and research in chemical engineering, biochemical and biological processes. 
  • Performed assigned lab tests and followed defined procedures for carrying out scientific investigations. 
  • Utilized scientific tests completed, maintained accurate laboratory write-ups of investigations.

 

 

 

Jewish Hospital – Louisville, KY          June 1994 to May 1999

 

Neurodiagnostics Technician

  • Prepared patients for sleep studies by administering a mini physical involving, blood pressures, heart rates, and pulmonary functions. 
  • Evaluated patients during sleep scored and reviewed results with patients using various forms and computers                                                       

 

 

July 1988 to June 1994         

Cardiology Technician

  • Performed EKGs, Signal Averaged EKG’s, and Holter Monitoring
  • Assisted with Echocardiogram   

 

         

July 1987 to July 1988                       

 Phlebotomist

  • Collected morning blood specimens from patients (arterial blood gases, venipunctures) 
  • Entered, charted, and reported all results via various computers

 

 

 

RESEARCH EXPERIENCE

 

                                                                                                                                                            

University of Louisville (Education) - Louisville, KY    January 2008 to December 2008

 

Engineering Research Assistant

  • Research involving the development of a Milk Transportation Security System
  • Cooke Tanabe, R., et al. 2008. Improving the Security and Logistics of Milk Collection and Transport 

 

 

The Scripps Research Institute– San Diego, CA          August 2000 to August 2001                                                                                           

 

Research Technician

  • Used state-of-the art mass spectrometry equipment toward solving bioanalytical problems.
  • Analytical methods include GC/MS and LC/MS
  • Instruments: Electrospray and MALDI-TOF

 

 

                                                                                                     

 

 

 

 

 

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