Quality Assurance Control

Missouri City, Texas ***** ( 281-***-**** (

**************@*********.***

SUMMARY

Highly motivated, goal oriented, and efficient Quality Assurance

professional with expertise in regulatory compliance, documentation,

auditing, and process improvements.

Known for ability to complete multi-faced tasks within strict time

constraints.

Demonstrated expertise in setting priorities and establishing

appropriate detailed documentation to meet deadlines using strong

clinical, analytical, and technical skills to analyze complex

processes and problems to develop innovative solutions to challenges.

PC literate with working knowledge of MS Office Suite, Windows XP, and

Internet

Excellent organization, communication, analytical skills, and research

abilities.

Able to read, analyze and interpret general business periodicals,

professional journals, technical procedures and governmental

regulations (GMP, GLP GCP, ISO)

Excellent time management, interpersonal and communication skills,

Knowledge of quality assurance, GMP, GCP, GLP, Product testing, In-

Process control, Process operations, statistical quality control,

experimental techniques and technical documentation, process

optimization and validation, cleaning validation on equipment,

development and validation of analytical methods, and FDA regulations,

Familiarity with US Pharmacopoeia, audit and non-conformance reports

for in line and in process tests, audits of the QC lab,

Reviewing laboratory records, corrective/preventative actions, raw

materials specification, writing SOP's, day to day operations,

calibration, physical tests, identity tests, assays, process

capability- yield enhancement,

Familiarity with sampling methods and applications, validation of

analytical methods, safety and waste management, chemical handling and

disposal, proficiency with Microsoft Office (Word, Excel, and Power

Point), and maintenance of the employee training program.

Work effectively with employees at all levels at the site regarding

Quality Management Systems development, Internal Auditing, Compliance,

CAPA and Management Review.

PROFESSIONAL EXPERIENCE

Karl Storz Quality Engineer 2011- Present

Support the creation, implementation and continuous improvement of the

client Quality Management System (QMS). Create and update processes,

procedures and policies with respect to the scope of operations at the

site. Ensure that the documented processes, procedures and policies

remain compliant with all applicable requirements and that these

documented processes, procedures and policies are properly implemented

and adequately understood throughout the sites' workforce. Support the

development and the distribution of best practices and "best-in-class"

processes. Support internal audits, supplier evaluation, CAPA program,

complaint investigations, engineering change reviews, non-conformance

program and programs which ensure continuous improvement of the Quality

Management System. Ensure that the established and implemented QMS

satisfies ISO 9001:2000, ISO 13485, the Canadian Medical Device

Regulations, and the U.S. FDA cGMP/QSR.

Cetero Research Quality Assurance Specialist 2009 - 2011

Participated and assisted with regulatory inspections and compliance.

Audited data and reports. Conducted in-process inspection, conducted on-

site facility inspections, consulted with facility personnel and served

as a resource on the interpretation and application of regulations.

Complied with Quality Assurance related Cetero Standard Operation

Procedures. Maintained a copy of the Master Schedule. Prepared and

retained written reports on audits, inspections and disseminated them to

management, study directors and appropriate personnel. Provided

management with reports on quality assurance activities. Reviewed

facility standard operation procedures for compliance and provided in-put

in updating the standard operation procedures. Maintained the document

change notice for Cetero SOP's and assured that the new SOP's were

circulated to all the departments. Reviewed protocols and protocol

amendments. Managed GMP training for new employees

Cogenics Quality Assurance Specialist II

2008 - 2009

Participated in the development, implementation, and maintenance of

quality systems, ensuring compliance with regulatory requirements 21 CFR

210, 211 and 820, cGMP/ GLP, ICH Q7A and ISO 9001:2000. Created a new

system for auditing that improved the efficiency of the audit process.

Planned, performed and hosted internal and external audits for compliance

to protocol, SOP's and FDA regulations. Successfully implemented an

advanced electronic documentation management system to digitize a paper

based system and to permit a systems approach to complaint management

that increased the efficiency of record retrieval. Developed,

implemented, and maintained the quality systems. Ensured that third-

party vendors and customers met quality standards. Updated training

manuals; coordinated and oversaw internal training courses. Assisted

with creating and supervising the execution of validation protocols.

Oversaw the maintenance of current and archived SOP's. Prepared reports

and records on calibration, inspection, and repair activities. Trained

staff on appropriate regulations and the revisions and implementation of

new procedures.

BA Research Documentation Specialist

2007 - 2008

Ensured the data and the documentation for assigned clinical research

projects were compiled and checked for accuracy and compliance and that

the data met all applicable SOP and applicable regulatory acceptance

criteria. Collected and organized research data for assigned studies.

Created routine reports on subject enrollment and general descriptive

information from the research database. Maintained clear and accurate

research data, inventories and logbooks. Maintained protocol binders

containing regulatory documentation. Ensured quality and integrity of

data. Provided orderly safe and secure maintenance of all assigned

research records. Ensured the completeness of documentation pertaining

to a study. Assisted with the preparation of interim and final technical

reports, summaries, and, protocols.

Cyberonics Clinical Engineer

2005 - 2006

Provided clinical research and customer technical support in-house as

part of the Complaint Handling process. Developed and maintained a

thorough and practical understanding of Cyberonics' products and

technology. Identified and investigated complaints in accordance with

Company policy, FDA regulations and other governmental agencies, as

applicable. Resolved resolution to inquiries regarding company products

received through the call center, email, or other sources. Determined

the severity of complaints by asking clinically relevant questions

regarding the nature of the failure, and/or consequence to the patient.

Worked with external medical personnel on investigations where analysis

of situations or data required clinical as well as technical knowledge.

Conducted an in-depth evaluation of various factors affecting the

clinical event. Authorized and processed product returns from customers.

Investigated instances of nonconforming material and facilitated the

determination of root cause, corrective action/preventive action and

recommendation of disposition. Provided clinical and technical support

to both internal and external customers. Participated in cross-

functional teams assembled to investigate and resolve product quality

issues.

Baylor College of Medicine Quality Assurance Quality Control Analyst

2001 - 2005

Responsible for the overall quality of all aspects of the operation of

the Gene Vector laboratory and the Cell and Molecular therapy Laboratory.

Tested organ transplant patients for Epstein Barr Virus. Established

and performed patient monitoring testing as designated by protocols to

determine safety. Assisted in maintenance of Quality Assurance / Quality

Control program. Performed equipment qualification and validation.

Performed general troubleshooting on laboratory equipment. Ensured that

preventative maintenance schedules for all equipment was established and

maintained. Maintained and troubleshot equipment as required. Performed

process validation related to all procedures in the program.

Planned, performed and hosted internal audits for compliance to protocol,

SOP's and FDA regulations. Assisted in development and maintenance of

standard operating procedures. Developed standard operating procedures

for all activities within the program. Ensured that these procedures

meet or exceed all relevant state and federal requirements of handling of

biological and cellular components and products. Updated procedures

according to changes in clinical or laboratory practice or regulations.

Assisted in training sessions related to the needs of the program.

City of Houston Microbiologist

1997 - 2001

Tested water and dairy samples from various sources for the presence of

coliform bacteria. Educated the public on ways to improve the quality of

their potable water. Tested bottled water, lakes, swimming pools, and

various other sources for the presence of total and fecal coliforms.

Tested milk and dairy products from different sources for the presence of

coliform bacteria, freezing point, absence of antibiotic residues,

quality of pasteurization, coliform content, and bacterial content.

Performed quality control in compliance with federal and state regulatory

agencies.

EDUCATION

BA in Biology, University of California

Berkeley, California 1993

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