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Quality Assurance Control

Location:
Allen, TX, 75002
Posted:
December 07, 2012

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Resume:

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



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