Engineering: Industrial Engineering
2008 Louisville, KY
Science: Industrial Engineering
Louisville December 2007
Science: Chemistry, minor Biology
Louisville December 1998 Louisville, KY
BSI AS9100C Lead
BSI AS9100D Auditor Training
IPC - J-STD-001 (Electrical Assembly Certification)
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
MS Office Minitab SAP Problem Solving
ISO 9001 SharePoint
Supply Chain CRF 211
SWE/Society of Women Engineers
ASQ/American Society for Quality
IIE/ Institute of Industrial
Engineers Golden Key International Honor Society
ENGINEERING EXPERIENCE – AEROSPACE / PHARMACEUTICAL
Hartford, CT March 2019 to August 2019
Engineer (Aerospace & Defense)
- Led Teams and managed the development and
implementation of process flow diagrams and PFMEAs.
- Reviewed blueprints, travelers and processes
for customer approval.
- Participated on MRB
- Worked with continuous improvement teams in
mapping processes for optimal delivery performance.
Technologies– Alpharetta, GA September 2018 to March 2019
Quality Engineer (Aerospace & Defense)
- Developed Customer PFMEA, and APQP for new
- Participated in 5S, Kaizen lean
- Conducted Pre-source
- Quality System Trainer and
Aircraft Products– Bohemia, NY March 2018 to Present
- Lead Auditor in the implementation of the
AS9100 revision D Quality Management System.
- Investigate, determine, and implement RCCA,
supporting CAPA, and continuous improvement activities.
/ Bentley Global Resources – Long Island, NY November 2017 to March
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
reoccurrence of quality findings.
Aerotek – Georgetown, KY September 2017 to November 2017
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 and internal requirement is met.
Mission Systems / American Contract Group (Aerospace) - Davenport, IA March 2017 to September 2017
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.
- 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
(Automotive) Frankfort, KY
November 2016 to February 2017
•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, and test activities. Interacted with internal departments at all levels and external customers and
•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
•Performed necessary PPAP’s and provided the necessary support to APQP activities.
•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
Grumman (Aerospace & Defense) – San Diego, CA August 2015 to August 2016
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
- 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; Provided 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
Labs (Pharmaceutical) – Bedford, OH February 2012 to August 2012
- 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
Novartis (Cold Supply Chain) – Louisville, KY February 2015 to July
Specialist – Contract Position
- Managed the review and approval of
transportation data; product returns, withdraws and recalls to ensure third-party distributors perform their services within the scope of the quality agreement.
- Participated in distributor compliance audits
and quality risk assessment of distributors.
- Collaborated with third-party distributors and
various V&D quality groups to approve V&D product specific work instructions and SOPs.
- Tracked CAPA/remediation plans; collaborated
with Global GMP compliance to ensure progress of audit CAPAs.
- 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 performed.
- Participated in investigations pertaining to
distribution excursions and/or deviation in collaboration with NVD quality units.
- PIP available to immediately triage quality
Pharmaceuticals – Little Rock, AR August
2014 to November 2014
Quality Assurance Analyst
- Ensured all controlled documents and records
met CGMP and ISO requirements
- Provided a high-level support through the
development and implementation of QMS.
- Conducted, reviewed, and updated, Quality
Investigations (Deviations, Product Complaints) Validation Plans, Protocols, Audits, Reports and Standard Operating Procedures
- 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
- Responsible for calibration
(Food Manufacturing) – Louisville, KY April 2014 to July 2014
Assurance Technician – Contract Position
- Responsible for periodic audits of plant and
product quality, GMPs, and QA practices. worked with production in identifying root cause of defect trends.
- Involved in Allergen control and hygienic restoration programs to ensure effectiveness and implementation; responsible for daily HACCP
- Performed attribute tests on both raw and finished product: color, texture, size, defect, flavor, and foreign material evaluation
- Responsible for reporting of, and investigation of, defect issues that occur during manufacture such as foreign material contamination.
Pharmatec (Pharmaceutical) – Seymour, IN August 2013 to November
Quality Assurance Technician – Contract Position
and sampled in-process production and incoming raw materials; oversight of stability program, reserve samples, inspection of manufacturing components and finished
- 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
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
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.
of Louisville (Research) – Louisville, KY November 2001 to May 2002
- 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.
Research Institute – San Diego, CA September 1999 to August
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, screened subjects, scheduled Sleep laboratory and clinical laboratory studies
- Demonstrated knowledge of the clinical research
setting, protocols, principles, and standards
- Managed patient
of California San Diego – San Diego, CA September 1999 to July 2000
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
LABORATORY / HEALTH CARE EXPERIENCE
Products – Louisville, KY July
2007 to February 2008
- 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 all laboratory equipment per the
manufacturer’s recommendations per Standard Operating Procedures. Quality equipment: GC/MS, UV, IR, Density Meter, Karl Fisher.
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.
Foreman (Distillery) – Louisville, KY March
1997 to March 1999
Laboratory Technician – Coop (Chemical Engineering)
- Developed and analyzed new
- 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.
Hospital – Louisville, KY June 1994 to May
- 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
July 1988 to June 1994
- Performed EKGs, Signal Averaged EKG’s, and
- Assisted with
July 1987 to July
- Collected morning blood specimens from patients
(arterial blood gases, venipunctures)
- Entered, charted, and reported all results via
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
Research Institute– San Diego, CA August 2000 to August
- Used state-of-the art mass spectrometry
equipment toward solving bioanalytical problems.
- Analytical methods include GC/MS and
- Instruments: Elect
- rospray and MALDI-TOF