Quality Engineering

RHONDA COOKE-TANABE

**** ****** **** ****, **** 1, San Diego, CA 92130 C: 502-***-**** Email: ************@*****.***

SUMMARY

Career Objective:

Pursuing a position that will enhance my current education and skills in Engineering, Science or Education

EDUCATION

Masters of Engineering: Industrial Engineering

December 2008

University of Louisville

Louisville, KY

Bachelors of Science: Industrial Engineering

December 2007

University of Louisville

Louisville, KY

Bachelors of Science: Chemistry, minor Biology

December 1998

University of Louisville

Louisville, KY

Certification: BSI AS9100C Lead Auditor December, 2015

Skills: AS9100C Auditor, GLP, GMP, CAPA, Change Control, HACCP, SQF, IQ, OQ, PQ, Regulatory Affairs, QMS, Document Control, FMA, 21CFR, SOP, QA/QC, SOW, Training, GC/MS/UV/IR/LC,

Microsoft (Word, PowerPoint, Excel), Minitab, SAP, Oversight of Multiple Operations, Analytical, Problem Solving, Time Management, Verbal Communication, Writing, Research, People Skills, Quick Learning Skills

RESEARCH

University of Louisville, Louisville KY

Research involving the development of a Milk Transportation Security System,

Research involving Bipolar Illness, Oubaine Binding and Rubidium Uptake

PRESENTATIONS

University of Louisville, University of Kentucky

Cooke Tanabe, R., et al. 2008. Improving the Security and Logistics of Milk Collection and Transport

AFFILIATIONS

SWE/Society of Women Engineers

IIE/ Institute of Industrial Engineers

Golden Key International Honor Society

ASQ/American Society for Quality

EXPERIENCE

Northrop Grumman– San Diego, CA

August 2015 to Present

Quality Engineer / AS9100 C Lead Auditor

Responsible for working within integrated teams to analyze, control and improve product quality; participates in investigations pertaining to distribution excursions and/or deviations in collaboration with the NVD quality units; assures clear identification, physical control and competent disposition of non-conformances

Facilitates corrective actions, closed loop process controls and continuous improvement methods to improve product/process predictability and capability; manage the interface and selloff of products to downstream operations or end item customer quality representatives

Successful at performing floor audits of production processes and procedures; evaluates manufacturing processes for compliance with quality requirements; successful at identifying processes where the organization is meeting the requirements as well as identify opportunities for improvement.

Manages and directs weekly internal audit functions to ensure company policies, procedures, and internal controls are designed and functioning to effectively and efficiently accomplish organizational goals; identify risks, control gaps, recommendations, and possible corrective actions, ensuring issues and observations are communicated before audit results are finalized and formally distributed.

Prepare detailed reports on audit findings and work with managers and staff to resolve non-conformances and deficiencies; works hands on with staff auditors, providing guidance in audit techniques, risk assessments, and audit report writing. Assist in the development of internal and external audit plans and audit schedules; worked directly with external auditors in successful renewal of company certification

Kaztronix / Novartis– Louisville, KY

February 2015 to July 2015

Quality Specialist – Contract Position

Successful in managing the review and approval of transportation data; product returns, withdraws and recalls

Ensure that the third party distributors perform their services within the scope of the Quality Agreement; responsible for Participating in distributor compliance audits; quality risk assessment of distributors and the ongoing monitoring process.

Collaborates with the third party distributor and various V&D Quality groups to approve V&D product specific work instructions and SOPs.

Responsible for tracking of CAPA/remediation plans,and ensure the progresses on the actions defined and collaborate with Global GMP Compliance in order to ensure the progress of audit CAPAs; provides support of cold chain transportation validation; identifies areas of improving UPS supply chain and drive improvement projects.

Provides local disposition of vaccine products at distributor location in coordination with various NVD site quality organizations. Work with third party Quality functions to ensure appropriate V&D specific training modules are developed and training is performed.

Participates in investigations pertaining to distribution excursions and/or deviations in collaboration with the NVD quality units.

Responsible for being PIP available to immediately triage quality issues as they occur and facilitate the communication flow between the contractor and the various V&D manufacturing sites and Global Quality Operations.

SCA Pharmaceuticals– Little Rock, AR

August 2014 to November 2014

Quality Assurance Analyst – Contract Position

Successful in working in fast paced environments; good writing, verbal, decision making and Organizational/ interpersonal skills. Developed complete working knowledge of cGMPs; ensures all controlled documents and records meet CGMP and ISO requirements

Provided a high level of understanding of relevant production processes and quality systems. Assist 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; Training staff on GMP and related task. Assists management in 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; maintains filing and archiving of 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. Responsible for issuance, review and approval of master batch records, labels, and other production documents in compliance with the requirements of the Customer and FDA.

Responsible for managing and implementing label process, reconciliation and sampling plan in accordance with FDA guidelines; usage of FMEA and made recommendation for continuous improvement and assist in providing guidance with strategies.

Responsible for calibration program; managing, revising and implementing; equipment, instruments and maintenance; logs, SOP’s and log books.

ConAgra– Louisville KY

April 2014 to July 2014

Quality Assurance Technician – Contract Position – 4/3/14 to 7/3/14

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; performs 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.

First Call Staffing / JLM Pharmatec– Seymour IN

August 2013 to October 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.

Ben Venue Labs – Bedford OH

February 2012 to August 2012 Validations 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

Responsible for preparation of test equipment and components in the execution of validation activities, and facilitating execution of IQ, OQ, PQ.

Support 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.

Validations Engineer Liaison

Interacted with operations, administration, quality assurance, maintenance, process engineering, project engineering, quality engineering in accomplishing continuous improvement in support of successful validation execution.

Developed a general understanding of process validation procedures and its applications (IQ, OQ, PQ)

Pharmaceutical Technician

Responsible for room set up, which included pre use inspection and verification of equipment

performed the core operations within the functional area (sealing and filling of products; movement of product components and equipment within the aseptic processing area)

Documented all work in controlled documents (batch records, log books, or SOP attachments) in accordance with SOP.

Responsible for fill checks, thermocouple placement, and measurement of tailings.

Developed a general understanding of FDA, cGMP and regulatory guidelines.

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 insure that research is conducted in compliance with local, state, and federal regulations.

Independently prepared and managed all regulatory submissions within the appropriate timeframe 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.

Cleveland State University – Cleveland OH

October 2010 to December 2010

Doctoral Graduate Assistant

Assisted in the recruitment of engineering students and coordination of the Fenn College of Engineering cooperative education program.

Pharmco AAPER – Shelbyville KY

June 2009 to October 2009

Senior Chemist

Managed and performed chemical analysis and quality control procedures on ethanol related products.

Quality equipment: GC/MS, UV, IR, Density Meter, Karl Fisher.

University of Louisville - Louisville KY

January 2008 to December 2008

Engineering Graduate Assistant

Assisted in the research of the development of a prototype bulk milk transportation security system

Allow users to track milk from farm to processor, ensuring milk security and safety.

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

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.

University of Louisville – Louisville KY

January 2006 to December 2007

Industrial Engineering Student

Pursuing courses in Industrial Engineering Program

University of Kentucky – Lexington KY

August 2003 to August 2005

Chemical Engineering and Research Student

Pursuing courses and research through Chemical Engineering Program

University of Louisville - Louisville KY

November 2001 to May 2002

Research Coordinator

Managed, coordinated, and conducted various research projects.

Served as principal coordinator of research subjects and patients; facilitate scheduling or appointments and follow-up visits, including summary assessments when needed.

Assisted in the planning, implementation and evaluation of project components.

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,

September 1999 to August 2000

Clinical Research 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 and delivery of specimens

University of Califronia San Diego – San Diego, CA

September 1999 to July 2000

Clinical Research Sleep Coordinator

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

Successfully interacted with research team. Educated performed and evaluated patients identified or treatments in the clinical sleep disorder-breathing program.

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.

Brown - Foreman Corp – Louisville, KY

March 1997 to March 1999

Laboratory Technician - Coop

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

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