Quality Assurance Control

RHONDA COOKE-TANABE

Email:************@*****.***

Phone: 502-***-****

SUMMARY

I’m a skilled and experienced quality professional with experience in regulatory compliance, quality assurance, quality control, project management, contract review, FMEA, CAPA, root cause analysis, quality investigations, supplier quality, quality auditing, validations engineering, quality training, manufacturing process engineering, APQP, Leadership, Management, Risk Analysis, quality managements system management, compliance engineering, continuous improvement, quality inspections, document control, SOP analysis, FAI, quality and manufacturing engineering. I’m looking for a challenging position to enhance and utilize my strengths and abilities in the mentioned, or other fields.

EDUCATION

Master of Engineering: Industrial Engineering

University of Louisville December 2008 Louisville, KY

Bachelor of Science: Industrial Engineering

University of Louisville December 2007 Louisville, KY

Bachelor 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

ISO 13485:2016 Statistical Process Control GLP, GMP, CAPA Trackwise

HACCP, SQF IQ, OQ, PQ Customer Service Quality Auditor Management System Document Control FMEA Change Control

SOP, SOW Quality Training GC/MS/UV/IR/LC MS Office

Minitab SAP Problem Solving Research ISO 9001 Analytical Thinking Operations Management Project Management CFR 211, 212

Cold Supply Chain Quality Metrics Manufacturing SharePoint

Microsoft Access First Article Inspections Continuous Improvement

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

Bastion Technologies – NASA Neil Armstrong Test Facility: Sandusky, OH/ Contract – February 2024 to Present

Principal Quality Assurance Engineer- (Space Center - Test Facility)

Principal; Quality Assurance Engineer for NASA ATF Testing Center.

Support Quality Assurance Functions for Major Test Programs

Perform independent verification and concurrence for hazard control countermeasures.

Review and manage documents, process plans, and check sheets that are undergoing development or editing for compliance with AS9100 and NASA Policy Directives.

Participate with ATF working groups, engineering, in process developments and improvements.

Trimble: Dayton, OH/ Contract - July 2023 to February 2024

Failure Analysis Lab Project Lead, OH- (positioning, control, and automation)

Project Lead for failure analysis lab continuous improvement activities.

Engage with team of Engineers in Failure Analysis Compliance projects.

Developed Capacity & Throughput Planning and Quality Management System Procedures.

Used Google Suite for projects and to interact with team of engineers

Boeing Aerospace: St Charles, MO/ Contract - October 2022 to April 2023

Sustaining -Supplier Quality Engineer (Aerospace, Aviation & Defense)

Worked with a team of manufacturing and quality experts in the oversight of Supplier Investigation and management of Boeing Product Quality Management systems, and their suppliers.

Provided Quality interpretation of company and regulatory requirements and supported material review dispositions and non-conformances.

Recommended corrective actions and root cause analysis to address non-conformances.

Supported and acted upon ongoing continuous improvement initiatives.

Managed supplier RMAs, notifications, corrective actions, product returns and shipments.

Supported management in the continuous improvement of supplier non-conformances.

Qualcomm: San Diego, CA/ Contract - July 2021 to February 2023

Quality Assurance Engineer (Semiconductor / Software / Wireless Technology)

Play a key role in supporting Quality Management systems (QMS) and Lab compliance in supporting Business Units and continuous improvement initiatives with internal teams.

Support the compliance QMS to ISO 9001:2015.

Design SharePoint internal sites with Power App, Power Automate, and Power BI tools migration.

Support Corrective/Preventive Actions and Lessons Learned at key product milestones to prevent recurrence of issues.

Create, review, and revise Standard Operation Procedures and Processes

Support the gap analysis and compliance of QCT for QMS standards related to upcoming and adjacent markets (e.g., ITF 16949)

Conduct Data Analysis and conveyed through PowerPoint presentations.

Business Analyst (Semiconductor / Software / Wireless Technology)

Assist Business Analyst with CCB (Change Control Board) Process via Agile.

Thales: New York, Overland Park Kansas / Remote - March 2021 to July 2021

Quality Assurance Manager (Aerospace, Aviation & Defense)

Managed the development and maintenance of ISO9001/AS9100 processes and documentation.

Reviewed and supported colleagues in ensuring that the processes comply with the minimum requirements of ISO9001/AS9100 and provide sufficient guidance to deliver products and services in line with customers’ expectations and contract requirements.

Provided quality monitoring of bids and programs both internally and in customer setting.

Advisor in regard to Regulatory requirements and their impact on the Company’s procedures and policies.

Direct and monitor activities for Document Control.

Monitored and evaluated activities of the employee; providing coaching, guidance, and training to ensure operational efficiency and adherence to company quality policies and procedures.

Toyota Boshoku: Erlanger, KY/ Remote December 2020 to March 2021

Capital Investment Specialist (Automotive)

Managed approval of capital investment and capitalized assets

Worked to enhance asset utilization and cost reduction.

Worked with team and other departments to develop short term and long-term capital investment plans and strategies based on the latest business assumptions.

Communicated with all functions to understand goals and cost impact for all investment proposals.

Supported justification and approval of capital investment budgets and purchase requisitions.

Confirmed that asset policies are followed and supported Accounting and Finance to close project books.

DAFCO): Louisville, KY February 2020 to October 2020

Quality Engineer (Aerospace & Defense Supplier)

Subject Matter Expert in Contract Review and implementation for Aerospace & Defense Contracts.

Lead Internal Auditor and auditor Trainer.

Customer Engineer for Boeing Airlines.

multiple suppliers for FAI Source Inspections and non- conformances.

Technical writing; established, reviewed, and revised, Standard Operation Procedures, Processes, and Work Instructions.

Hands-on experience with the ISO9100 and AS9100 Quality Management Systems Processes

Development of training for ISO 9001 and AS9100

Root Cause Analysis, CAPA Expert

SMS Solutions: Seattle, WA December 2019 to March 2020

Supplier Quality Engineer (Aerospace & Defense)

Project managed multiple suppliers for FAI Source Inspections and non- conformances.

Performed Aircraft Parts and Material Conformity Inspections

Conducted FAI Source Inspections according to AS9102 (FAI) Protocol

Exhibited an understanding of Special Processes (i.e., heat treating, welding, NDT)

Established part quality evaluation plans from materials requests through material receipt (full life cycle).

Provided resolution and disposition of non-conformance materials to ensure adequate corrective action.

Implemented closed-loop processes such as problem-solving skills and root cause analysis to determine the potential effectiveness of proposed corrective actions.

Interpreted Engineering Mechanical Processes, Standard Drawings Conventions, Specifications, and GD&T

Hands-on experience with the ISO9100 and AS9100 Quality Management Systems Processes

Knowledge of FAA, EAR, and ITAR standards and regulations

Triumph – Hartford, CT March 2019 to September 2019

Quality Engineer (Aerospace & Defense) Contract Position

Led teams and managed the development and implementation of Process Flow Diagrams and PFMEAs.

Reviewed blueprints, travelers, and process for customer approval.

Participated on MRB committee.

Worked with continuous improvement team in mapping processes for optimal delivery performance. Worked with CMM and machining processes.

Work independently and within groups to analyze and solve customer issues.

L3 Technologies– Alpharetta, GA September 2018 to March 2019

Sr. Quality Engineer (Aerospace & Defense)

Responsible for developing Customer PFMEA, and APQP for new product development.

Responsible for Coordinating/developing/monitoring/maintaining necessary procedures, controls, and/or programs to assure compliance/conformance to regulatory, customer, and company requirements; Performed product quality audits to assure compliance with customer, drawing, internal, and regulatory requirements.

Responsible for Supporting Operations to ensure that products and processes comply with the relevant requirements of the quality management system. Work with Vendor Approvals, Customer Corrective Actions and Quality Objectives.

MRB/ECN Board representation and duties

Help establish and monitor Key Process Indicators (KPIs).

Responsible for participating in continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods; Managed, schedule and conducted pre-source inspections. .

Quality System Trainer and coordinator

Worked with assembly and communication display modules.

Davis Aircraft Products– Bohemia, NY March 2018 to September 2018

Compliance Quality Engineer (Aerospace)

Lead auditor in the implementation of the AS9100 revision D Quality Management System.

Investigate, determine, and implement RCCA, supporting CAPA, and continuous improvement activities

Work with Vendor Approvals, customer Complaint Investigations and customer corrective Actions and Quality Objectives (metrics).

Quality System Trainer and coordinator

Worked with machining component processes.

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

Quality Engineer (Aviation Contract Position

Quality Assurance: Supported implementation AS9100 revision D (AS9110 revision C) Quality Management System.

Quality Compliance: Government source inspector for final inspection of electrical assemblies and implement process improvements to eliminate reoccurrence of quality findings.

Source Inspector for MRO (Electrical Circuit Boards, Communication modules)

Auditor for MRO and FAA (Title 14 part 145) regulations.

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.

Responsible for the development and modification of procedural documents. Conduct training on quality assurance concepts and tools; interpreted engineering drawings and specifications.

Worked with explosives & Oxygenated Systems

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. Responsible for resolving customer complaint investigations and any additional issues during the process and development process.

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, Liaison to customer PQE’s and other quality representation for new product development.

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 customer complaint investigations.

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. Maintain records of audits and findings to document compliance.

Prepared detailed reports on audit findings and worked with managers and staff to resolve non-conformances and deficiencies; mentored 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.

QUALITY EXPERIENCE – PHARMACEUTICAL/ FOOD/ SUPPLY CHAIN

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

Quality Specialist – Contract Position Contract Position

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

Participated in distributor compliance audits, product safety 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 ensured progress on the actions defined. Collaborate with Global GMP Compliance to ensure the progress of audit CAPAs; identified areas of improving UPS supply chain and drove improvement projects.

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 is performed.

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

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

Quality Assurance Analyst

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. Made 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; Trained staff on GMP and related task.

Performed 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; 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; made recommendation for continuous improvement and assist in providing guidance with strategies.

Managed calibration program/

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; 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; completeness, and compliance with specifications and food safety regulations prior to releasing products to warehouse for shipment to customers.

Used Statistical Process Control in monitoring the creation and delivery food manufacturing processes.

Responsible for accepting / rejecting decisions on finished product blends based on company / customer specifications.

Performed attribute tests on both raw and finished product: analyzed incoming ingredients in accordance with approved test methods, in process finished products, and R&D samples for specifications. Responsible for reporting and investigating 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.

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 (Pharmaceutical) – Bedford, OH February 2012 to August 2012

Validation Engineer Company Closed

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).

QUALITY EXPERIENCE – CHEMICAL

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

Senior Quality Control Chemist

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

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

Parallel Products (Chemical / Ethanol) – 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.

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

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.

CLINICAL RESEARCH / REGULATORY EXPERIENCE

University Hospitals ( Healthcare) – 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 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.

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 (Research) – 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.

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