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Quality Engineer Manager

Phoenix, AZ
December 29, 2020

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Joseph F. Smithes

*** * ******* ***

Gilbert, AZ 85233

Mobile: 317-***-****

Or 317-***-****

Professional Experience

Over Ten Years in the Medical

Device/Pharmaceutical/ Cosmetics


Supplier, Internal & Regulatory Audits

Confirmed Regulatory Compliance

before Product’s Final Release

Developed and Monitored Statistical

Process Control Studies

Process Validation

Established Quality Assurance Management

Systems for Raw Materials, Labels and

Packaging Material

CAPA, Root Cause and Risk Analysis creation

and implementation

Risk Analysis

Product Validation

Equipment Qualifications

GMP Staff Training

Point of Contact for FDA & EPA Audits

NSF Regulations

Quality Document Review & Product


Skillful practice of FDA 21 CFR Part 820,

Parts 210 & 211 Code of Federal

Regulations, ISO 9001, 13485


M.B.A., Indiana Wesleyan University, Indianapolis, IN B.S. Biology, I.U.P.U.I. – Purdue Degree Indianapolis, IN Associate of Chemical Technology, ITT Tech Indianapolis, IN Professional Certifications

Certified Manager of Quality/Organizational Excellence (ASQ Cert No. 56232) Certified Quality Engineer (ASQ Cert No. 99060)

Six Sigma Black Belt Professional (MSI No. 16716582) Regulatory Affairs Certification U.S

Certified Pharmaceutical GMP Professional (ASQ Cert No. 573) ISO 9001 Lead Auditor (PECB Cert No. QMLA1023690-2018-01) Technical Skills

Chemical Technology ITT Tech, Indianapolis, IN

Microsoft Office-Excel

SAP Experience

OSHA-Health Hazard Awareness

QI Macros 2018

Professional Work Experience

Abbott Laboratories, Scottsdale, AZ (Contract through ProKatchers, LLC) Validation Engineer III

September 2020-Present

• Developed and executed validation documents (I.e. IQPs & OQPs) for pacemaker manufacturing equipment

• Reviewed completed protocols and wrote validation reports (I.e. IQRs & OQRs).

• Authored document changes and change control documents to update protocols Paragon Vision Sciences, Gilbert, AZ

Sr. Quality Engineer

November 2019-May 2020

• Developed and Reviewed IQ,OQ & PQ’s for compliance and feasibility.

• Reviewed and approved qualification reports

• Investigated and resolved NCRs and Deviation Reports

• Initiated and finalized quality improvement projects R&R Lotion, Inc., Scottsdale, AZ

Quality Assurance Manager / Quality Validation Engineer June 2015-October 2019

OTC FDA Regulated Facility

• Audit plan development, execution and

operative follow up using ISO 9001 & FDA

21 Parts 210 & 211 Regulation Guidelines

and Rules

• Reviewed and updated SOP to reflect

current practices

• Established Environmental Monitoring

Program with Microbial Analysis

• Batch Record and SOP creation

• Batch record review and release

• Initiated, completed, and monitored

effectiveness of Change Control, OOS, CAPA

and Deviation reports

• Developed and monitored statistical trend


• Developed statistical capability studies

• Investigated and analyzed root cause of

Non-Conforming Production Material

• Coach, train and evaluate quality personnel

on their duties.

• Developed, executed, and scrutinized

Process Validation (IQ, OQ & PQ)

• Established, implemented, and monitored

Cleaning Validation

• Developed and accordingly monitored Raw

Ingredient Inventory system.

• Lowered Raw Ingredient annual costs by


• Worked with Chemist to execute

experiments to gather OTC empirical data

• Obtained EPA state registrations for new

product with active ingredient

• Obtained FDA registration for OTC products

• Maintained calibration, pest control and

personnel training records

• Daily contact with Suppliers, Distributors

and Testing laboratories for day to day

Supply Chain needs

• Established customer relationship

• Developed, performed, and checked

Equipment Qualification

Test-America, Phoenix, AZ

Project Management Assistant

May 2014-April 2015

• Processed Customer’s orders

• Monitored progress of client’s work orders and relayed status of laboratory works

• Review client’s chain of custody paperwork for accuracy

• Contact and confirm client’s chain of custody requests

• Facilitated client phone calls and direct to proper Test-America employees

• Review client reports for accuracy and completeness

• Place customer container and bottle orders for sampling purposes AMBU King System, Noblesville, IN

Quality Assurance Supervisor

June 2013-March 2014

• Audit plan development, execution and

operative follow up using FDA 21 Part 820

Quality System Regulation and ISO13485


• Provided Leadership to QA team by

evaluating cGMP and workflow concerns

• Supervised Production areas for adequate

QA personnel coverage

• Revised Device History Records to reflect

current and proper practices

• Reviewed DHR for accuracy and


• Investigated and analyzed root cause of

Non-Conforming Production Material

• Trained QA team to ensure up-to-date

cGMP and SOP training

• Evaluated QA teamwork performance

metrics using SPC tools

• Scheduled daily QA team’s functions

• Communicated adverse trends and non-

conformances to engineering and


• Performed document control specialist


• Maintained and managed various quality


• Communicated with Production Supervision

concerning QA issues

• Assisted in continuous improvement


• CAPA, MRB and Lot release documentation


Sigma-Tau Pharma-source, Inc. Indianapolis, IN

Senior QA Inspector

April 2012-May 2013

(Kelly Services at Sigma Tau)

Consultant Supervisor

Jan 2012-March 2012

• Inspected incoming supplier components

• Performed Quality Assurance checks on

cleanroom activates

• Assured the clearance and release of work

areas, including sterile injection sites

• Supervised cGMP attributes for releasing

areas for production; proper materials,

sanitization, equipment calibration PPE,

training and signatures

• Performed AQL of manufactured drug


• Performed In-Process Document review for

manufacturing instruction adherence

Roche Diagnostics, Indianapolis, IN

Senior Scientific Specialist

Feb 2005 -Dec 2010

(Adecco at Roche Diagnostics)

Temporary Senior Scientific Specialist

Sept 2004-Feb 2005

• Performed QA checks to monitor proper use of documents, personnel, and equipment

• Supervised and retrained employees to use the designated cGMP and SOPs

• Manufactured over 600 products which include calibrators, controls, and reagents for Drug of Abuse Testing (DAT) and Therapeutic Drug Monitoring (TDM)

• Maintained work area to be ISO 13485 and FDA 21 CFR Part 820 inspection ready

• Assisted in-process team in increasing total document accuracy rate of detailed manufacturing instructions

(DMI) from 60% to 97% by not producing a rejected document in over three years.

• Performed In-process and completed detailed manufacturing instructions reviews

• Represented department in multiple FDA, ISO, USDA and Internal Quality audits resulting in no significant observations

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