Quality Engineer / Analyst

Jimi D. M. Dyson

**** ******** ***, *** #* Indianapolis, IN 46240

317-***-**** *******@*****.***

Experienced M.B.A. Scientific Professional

Professional Profile

Experienced M.B.A. professional with over seventeen years of manufacturing, laboratory, medical device, and quality experience in cGLP/cGMP environments; Prior experience with Quality System Regulations/Medical Device cGMP, qualifications, installation and operational validation, and preventative maintenance; Proven ability to analyze, integrate, and report analytical data in laboratory and manufacturing settings; Proven ability to deliver, review, audit, and author technical documents, SOP’s, stability assessments, and method validations; Ability to lead and encourage people, provide the appropriate staff with testing and stability results in accordance with applicable government regulations and standards; Ability to audit and investigate processes, and operate and/or troubleshoot analytical equipment in a medical device and pharma facility under FDA QSR 21 CFR Part 820 and ISO13485 standards.

Acquired Skills

Master’s Degree

People/Team Leadership

Technical Author

Medical Device Support

Data Audits/Documentation

Excursion Review

QA/QC/FDA Experience

Installation and Validation

Data Qualification

Root Cause Analysis

Preventative Maintenance

CAPA Review

Education

Walden University Minneapolis, MN

Master of Business Administration; Marketing

Jackson State University Jackson, MS

Bachelor of Science and Technology, Biology

Professional Related Experience

Roche Diabetes Care, Inc. Indianapolis, IN

Senior Quality Engineer July 2014 ~ present

Currently serving as a people leader, and responsible for guiding a small team in quality management and complaint handling while demonstrating GMP and quality initiatives within the meter test laboratory and software test laboratory of a quality organization. Serving as a liaison between Global Complaint Management and Product Support and R&D

Responsible for preparing and executing validation documents and possessing a working knowledge of the principles of validation as associated with performance of work for the Diabetes Health organization.

Responsible for demonstrating protocol development skills will include ability to develop Installation, Operational and simple performance qualification documents with additional work in one or more validation subjects; such as laboratory equipment, facilities utilities, process equipment, packaging equipment, cleaning, computers, HVAC or controls.

Performs quality reviews, data qualification, technical writing, and excursion analysis; serves as author and reviewer of deviation assessments, investigations, interviews, and OOS and OOR reviews

Serving as Team Lead on various projects, utilizing CAPA and SAP systems, root cause analysis, handling adverse events, OOS excursions, corrective and preventative actions, performing method and process validations and qualifications to ensure FDA-regulated compliance within critical timeframes

J. Dyson

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ProPharma Group Multiple Client Sites

Senior Validation Engineer 2013 ~ 2014

Responsible for leading a team in technical writing and demonstrating GMP and quality initiatives within pharmaceutical, medical device, manufacturing, and bio-tech organizations

Responsible for preparing and executing validation documents and possessing a working knowledge of the principles of validation as associated with performance of work for the Pharmaceutical, Biotechnology and/or Medical Device industries

Responsible for demonstrating protocol development skills will include ability to develop Installation, Operational and simple performance qualification documents with additional work in one or more validation subjects; such as laboratory equipment, facilities utilities, process equipment, packaging equipment, cleaning, computers, HVAC or controls.

Performs quality reviews, data qualification, technical writing, and excursion analysis; serves as author and reviewer of deviation assessments, investigations, interviews, and OOS and OOR reviews

Serving as Team Lead on various projects, utilizing CAPA and Trackwise systems, root cause analysis, handling adverse events, OOS excursions, corrective and preventative actions, performing method and process validations and qualifications to ensure FDA-regulated compliance within critical timeframes

Responsible for representing ProPharma Group and division at client sites and interact confidently with clients, contractors, management and peers

Traveling 75 – 100%

ProPharma Group Multiple Client Sites

Senior Compliance Consultant 2012 ~ 2013

Responsible for quality initiatives within medical device and bio-tech organizations

Performs quality reviews, data qualification, technical writing, and excursion analysis; serves as author and reviewer of deviation assessments, investigations, interviews, and OOS and OOR reviews

Serving as Team Lead on various projects, utilizing CAPA and Trackwise systems, root cause analysis, handling adverse events, OOS excursions, corrective and preventative actions, performing method and process validations and qualifications to ensure FDA-regulated compliance within critical timeframes

Traveling 75 – 100%

Indiana Blood Center Indianapolis, IN

Production Technician 2010- 2012

Responsible for manufacturing whole blood into RBC, plasma, and platelets in a time sensitive manner

Utilized scales, centrifuges, bacterial detection testing, calculations, analyzers, and temperature monitors

Adhered to SOP’s, IBC safety policies and procedures, use of PPE, while being exposed to bio-hazardous materials and potential blood borne pathogens, and extreme temperatures

Utilized routine calibration skills, troubleshooting and repair techniques, visual acuity, manual dexterity, attention to detail, project management, and multi-tasking capabilities

Reviewed and validated technical documents, SOP’s, policies, and procedures

J. Dyson

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Eli Lilly and Company Indianapolis, IN

Quality Control Associate 2004-2010

Responsible for analytical, visual, and functional incoming testing and final release testing prior to manufacturing release

Served as the CAPA Trackwise author and investigator for the QC laboratory located within a cGMP, FDA-regulated environment for medical devices and components

Participated in daily routine calibrations, maintenance of records, and equipment repairs

Conducted analysis of biological/chemical resamples prior to market release; maintained stability study documentation and records based on retention guidelines in time and temperature sensitive environments

Performed quality review of testing data, and informed appropriate personnel of deviations that may affect integrity of the data; participated in corrective actions if applicable

Assisted in performing method development, qualification, and validation in a variety of matrices

Authored process improvement initiatives; resourceful with troubleshooting instruments and software

Eli Lilly and Company Indianapolis, IN

Relief Sales Representative 2008-2009

Responsible for providing life-changing solutions in the area of Diabetes Health to doctors, educators, health care providers, and other office staff

Offered assistance through educational materials, support, and samples to health care providers that are committed to helping diabetics live a better, healthier life

Performed this role as part of a job swap initiative; Required 75% travel and weekend work days

Eli Lilly and Company Indianapolis, IN

Technician 2001-2004

Responsible for providing accurate, reproducible data in a timely fashion by executing the necessary laboratory procedures to support decisions

Performed potency, related substances, and chiral assays on stability and in-process assays using GC, HPLC, and Wet Chemistry testing.

Utilized GCDS, second person verification, and the provision of data to support method development and data validation as required within a cGMP, FDA-regulated environment

Roche Diagnostics Corporation Indianapolis, IN

Process Improvement/Development Scientist 2000-2001

Responsible for process troubleshooting with the Accu-Chek Advantage product line

Managed feedback and implementation of product improvements to satisfy quality issues and product claims

Assisted with manufacturing process improvement initiatives for reject strip lots

Roche Diagnostics Corporation Indianapolis, IN

Diabetes Customer Care Specialist 1998-2000

Responsible for offering consistent customer service at an optimal level via telephone and in person

Marketed products, provided education and troubleshooting with diabetes patients on the usage of blood glucose products

Offered further education and assistance in patient’s daily monitoring activities

J. Dyson

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AFFILIATIONS

~ Roche African-American Business Resource Group Membership Lead (Membership Outreach)

~ Roche Women’s Leadership Initiative Mentor / Mentee and Campus Programming Committee Member

~ Roche Young Professionals Team Member

~ Roche JDRF Campaign Building Captain

~ Roche American Diabetes Association Tour de Cure Building Captain

STRENGTHS AND AREAS OF EXPERTISE

~ Excellent written and verbal communication skills

~ Proficient audit, investigation, and review techniques

~ Proficient with routine calibration and trouble-shooting techniques for laboratory equipment

~ Proven ability to deliver, review, and author technical documents, SOP’s, procedures, and methods

~ Proficient with installation, qualification, validation, and support of new instrumentation and procedures

~ Excellent problem-solving, technical, and organizational skills

~ Proficient with lab support and laboratory systems

~ Able to investigate, gather info, analyze, and report results appropriately and efficiently

~ Careful and explicit with concepts, meanings, and relationships

~ Exhibits attention to detail and project-oriented

~ Ability to deliver excellent technical writing documents with quality, timeliness, and efficiency

~ Clear understanding of manufacturing processes, policies, and equipment

~ Works well independently or in collaborative group environments

~ Proficient with ISO 13485 standards and requirements

~ Proficient with cGMP, GLP, SOP’s, Microsoft systems, SAP, and CAPA Trackwise

~ Trained in GC, HPLC, Wet Chemistry, quality analysis, assessments, and investigations

~ Laboratory oriented (over 15 years experience) in a FDA-regulated environment

~ Ablility to adapt to changes, environments, and requests with ease

~ Ability to manage peers and subordinates

~ Participated in LEAN Six Sigma activities and extensive experience in project management

~ Participated in product marketing, branding, pharmaceutical sales, and formulary access

~ Participated in communications strategy, business development, and creative management

~ Bachelor Degree in Science and Technology (Major – Biology)

~ Master’s Degree in Business Administration (Major – Marketing and Sales Management)

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