Joseph F. Smithes
Gilbert, AZ 85233
Mobile: 317-***-****
Or 317-***-****
adi1ak@r.postjobfree.com
Professional Experience
Over Ten Years in the Medical
Device/Pharmaceutical/ Cosmetics
Industries
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
Release
Skillful practice of FDA 21 CFR Part 820,
Parts 210 & 211 Code of Federal
Regulations, ISO 9001, 13485
Education
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
analysis
• 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
18%
• 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
Guidelines
• 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
completeness
• 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
production
• Performed document control specialist
duties
• Maintained and managed various quality
records
• Communicated with Production Supervision
concerning QA issues
• Assisted in continuous improvement
projects
• CAPA, MRB and Lot release documentation
experienced
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
products
• 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