Objectives
Quality professional seeking an opportunity to apply my previous training,
experience and skills to a quality-focused organization. Some of my
strengths include Quality Systems, FDA experience and knowledge, ISO 9001,
QA/QC/Regulatory, strong analytical skills, corporate training, Health and
Safety, and chemical systems. I enjoy working with people and I work well
independently.
Professional Experience
|RCO Consulting Service |2011-Present |
Title: Lead Quality Auditor
. Supplier quality system audits for pharmaceutical and medical device
manufacturers per 21 CFR 210 & 211; ICH Q7A; IPEC; 21 CFR 820; ISO
9001; ISO 13485
. SOPs
. Training
. Remediations
|BeautiControl, Inc. |2010- 2011 |
Title: ISO Management Representative/Internal Auditor/Document Control
Carrollton, Texas
. Organize Management Review Meetings
. Conducts Internal Audits per 21 CFR 210 & 211 and ISO 9001:2008
. Manage Document Control per 21 CFR 210 & 211 and ISO 9001:2008
|Cosmetic/OTC Drug Manufacturing |2009 - 2010 |
Title: Director of Quality Assurance and Regulatory Affairs
Dallas, Texas
. Ensured that OTC and cosmetic manufacturing meet FDA quality system
requirements
. Manage/supervise Quality Control Laboratory
. Quality Management System, including document control, product
specifications, non-conformance issues, complaints, supplier
corrective actions, and corrective and preventive actions and MSDSs
|Quest Medical, Inc. |2007 - 2008 |
Title: QC/QA Supervisor
Allen, Texas
. Monitored manufacturing GMPs to maintain compliance with FDA
regulations
. Managed/supervised the in-process analysis of medical devices.
. Internal Quality System audits
|Food and Drug Administration |2002 - 2007 |
Title: Investigator
4040 North Central Expressway, Suite 300
Dallas, Texas
. Planned/conducted regulatory inspections, Quality System Audits and
investigations of manufacturers of pharmaceuticals, medical devices,
foods, biologics, and clinical trials to establish compliance with the
FD&C Act, GMPs, GCPs and GLPs.
. Evaluation multiple technical disciplines such as engineering
technology, production, quality assurance, supplier/supply chain and
software.
. Performed analyses and evaluation of complex data samples. Documented
results.
. Interviewed various levels of management subject to regulatory review.
. Prepared affidavits, collected/analyzed data, prepared final
investigative reports.
|Texas Instruments |1993 - 2002 |
KFAB
Title: Manufacturing Specialist
Dallas, Texas
. Manufactured semiconductor devices in photolithography area.
. Conducted classroom/hands-on training/certification of new and old
hires.
. Quality control of reticles.
Twinstar Semiconductor, Inc. (owned by Texas Instruments)
Title: Analytical Chemist/Environmental, Safety and Health
Specialist/Hazmat Technician
Richardson, Texas
. Site startup
. Managed special projects in environmental, safety, and health group.
. Developed/presented monthly safety training.
. Conducted plant safety inspections, following up with corrective
actions.
. Involved in coordinating and implementing startup of analytical
chemical lab.
. Conducted routine analysis of chemicals and DI water.
. Certified Hazmat First Responder
Dallas Chemical Center
Title: Supervisor Chemist
Dallas, Texas
. Supervised particle counting lab for quality control of manufactured
chemicals.
Chemical Information System
Title: Chemist
Dallas, Texas
. Compiled Chemical/MSDS database for EHS use and reporting.
|Office of the Texas State Chemist |1986 - 1993 |
Title: Analytical Chemist
Texas A&M University
College Station, Texas
. Analyzed feeds and fertilizers to ensure compliance to the
manufacturers' labeling
. Supervised support personnel by training and assignments.
Education
|Texas A&M University |College Station, Texas |
Biochemistry