Austin Community College—Austin, Texas

Associate Professor (September 2009 to Present)

• Teach microbiology lecture and laboratory class to students in the Health Sciences.
• Manage laboratories for courses taught at the Riverside Campus
• Supervise laboratory personnel

Austin Community College—Austin, Texas

Adjunct Professor (September 1992 to August 2009)

• Teach microbiology lecture and laboratory class to students in Health Sciences. 

CERTIFICATIONS

REGISTERED MICROBIOLOGIST – AMERICAN ACADEMY OF MICROBIOLOGY

AAM RM Clinical and Public Health Microbiology #5310230 January 1993

AAM RM Consumer Products and Quality Assurance Microbiology #5310230 July 1994

TECHNOLOGIST IN MICROBIOLOGY – AMERICAN SOCIETY FOR CLINICAL PATHOLOGY

ASCP M Technologist in Microbiology #03381390 Associate Member 1994

CERTIFICATION IN EPIDEMIOLOGY

Epidemiology Southwest Texas State University, December 2002

CERTIFICATION IN BIOSTATISTICS

Biostatisics Texas State University-San Marcos, December 2004 

EXPERIENCE

Hospira (Formerly Abbott Laboratories)-Austin, Texas

Hospira is a speciality pharmaceutical and medication delivery company launched from the core global hospital products business of Abbott Laboratories.

Laboratory Manager (March 2003 – August 2009)

Managed several different laboratories through employment at Hospira.

Biological Quality Manager

• Manage a Staff of 46 employees for a large volume parenteral pharmaceutical company.
• Responsible for Microbiological, Particulate, Environmental Monitoring Laboratories, and the Environmental Control Program.
• Responsible for final product microbiological testing of finished products.
• Supported annual qualifications for depyrogenation oven, laboratory and product batch autoclaves.
• Led initiatives to streamline laboratory practices and process in order to reduce cost by 300M.
• Responsible for the optimization of investigation reports which led to reduction of open environmental investigation by 50% in 2003.
• Six Sigma Green Belt certified October 2004.
• Responsible for environmental control and cleaning for ISO Class 8 and ISO Class 7 manufacturing areas.
• Participated in cGMP peer audit as microbiological expert for sister Hospira manufacturing facilities.
• Responsible for FDA and third party audits as Hospira microbiological representative.
• Trained new employees in cGMP and microbiological practices.
• Coach and develop direct reports to facilitate a self-managed work group.

Chemistry Manager

• Manage the CQ department of 22 technical personnel.
• Act as the Plant technical contact with the Food and Drug Administration on CQ laboratory functions.
• Provide direct assistance to department personnel in problem solving activities.
• Act as the Plant Chemist, making recommendations on handling, storage, and disposal of chemicals.
• Deal with vendors through visits to their production and control facilities, as well as, with vendor
• representatives within Hospira plants to insure prompt resolution of quality problems.
• Establish and maintain budgets and expenditures for CQ areas.

Chemistry/In-Coming Quality Manager (March 2005-August 2008)

• Set direction for IQ/CQ Staff and supervise daily activities. Hire, train, develop and evaluate staff.

• Assist in resolution of problems by providing direct technical assistance or by obtaining assistance from Corporate or other Hospira locations.
• Provide authorization for the release or disposition of raw material, in-process materials, or final product.
• Act as the Plant technical contact with the Food and Drug Administration, Drug Enforcement Agency, etc., on IQ and CQ laboratory functions.
• Act as the contact (focal point) for other Hospira sites to improve the efficiency of IQ and CQ laboratories.
• Maintain close surveillance of all testing, sampling, and handling of drugs to assure reliability of work.
• Provide direct assistance to department personnel in problem solving activities.
• Assist in the development of improved testing methods and modification of existing official compendial tests.
• Provide testing support and technical knowledge in support of the Corporate and Plant durables and cleaning programs.
• Act as the Plant Chemist, making recommendations on handling, storage, and disposal of chemical (drugs).
• Deal with vendors through visits to their production and control facilities, as well as, with vendor representatives within Hospira plants to insure prompt resolution of quality problems.
• Evaluate and approve Standard Operating Procedures and Specification Change Requests originating in IQ and CQ.
• Establish and maintain budgets and expenditures for IQ and CQ areas.

ALK-Abello Incorporated—Round Rock, Texas

Division of Chr. Hansen, which manufactures Treatment Sets and Allergenic Extracts for the treatment of the allergic patient.

Quality Control Manager (December 2000 to March 2003)

• Managed Quality Control staff for a small volume parenteral pharmaceutical company. Responsible for Chemistry Laboratory, Microbiology Laboratory, Labeling/Inspection, Animal Laboratory, and Final Review/Release of Finished Product.
• Responsible for all final product release testing for glycerin and aqueous allergenic extracts:
• Radial Immunodiffusion, Competition ELISA, Safety Testing, Sterility Testing, Preservative Testing.
• Led projects to support compliance initiatives in response to FDA audit observations: WFI PQ, Final Product Inspector Qualification, Bacteriostasis/Fungistasis, Product Stability Testing,
• Cleaning Validations of Product Surfaces.
• Supported method development for major allergen quantification in Hercules Project.
• Responsible for validation of all final product release assay methods.
• Initiated training of all employees in FDA Good Manufacturing Practice Regulations for the Biologics Industry.
• Worked with ALK-Abello affiliate, Center Laboratories NY, to consolidate Safety and PNU testing.
• Collaborated with Quality Assurance and Manufacturing to upgrade documentation to comply with cGMPs: SOPs, Exception Reports, IQ/OQ/PQ of major process and method validations.
• Responsible for representing ALK-Abello during audits by FDA and USDA regulators.
• Responsible for implementing the start-up of new microbiology and animal testing laboratories in compliance with cGMP, FDA, and USDA regulations.
• Implement new cleaning agents in manufacturing to ensure a control environment for class 100,000 class 10,000, and class 100 areas: Vesphene, LpHst, Spor-Klenz.

McNeil Consumer Healthcare Company—Round Rock, Texas

Division of Johnson & Johnson, which manufactures and sells nonprescription pharmaceuticals that includes complete lines of Tylenolâ Acetaminophen and Motrinâ Ibuprofen products.

Microbiology Laboratory Manager/Senior Microbiologist (February 1994 to December 2000)

• Supervised and coached microbiology laboratory staff on company policies and procedures.
• Managed the performance of microbiological testing of raw material, drug products, and in-process materials to ensure compliance with current Good Manufacturing Practices (cGMP) regulations.
• Validated new testing equipment and analytical methods.
• Trained microbiology personnel to analyze aerobiological and water data.
• Led investigations of out-of-specification results for products, raw materials, USP and potable water, and environmental samples.
• Conducted performance qualification, maintenance, and the calibration of all microbiological laboratory equipment.
• Wrote and revised laboratory Standard Operating Procedures.
• Initiated and completed the Performance Qualification for McNeil’s USP water system.
• Managed the completion of cleaning validations for manufacturing and packaging equipment.
• Championed for McNeil’s microbiology Biosafety program in accordance with J&J regulations.
• LIMS experienced.

McNeil Consumer Healthcare Company—Round Rock, Texas

Division of Johnson & Johnson, which manufactures and sells nonprescription pharmaceuticals that includes complete lines of Tylenolâ Acetaminophen and Motrinâ Ibuprofen products.

Quality Assurance Supervisor (October 1995 to December 2000)

• Supervised Quality Assurance staff of seven for a solid dosage pharmaceutical company.
• Managed auditing of manufacturing materials and inspections of components.
• Reviewed documents to insure compliance with FDA regulations.
• Trained new employees in FDA Good Manufacturing Practice Regulations.
• Evaluated and initiated Process/Equipment Validations (IQ/OQ/PQ) for manufacturing and packaging equipment.
• Supervised the issue, review, and maintenance of production batch records.
• Collaborated with Engineering and Manufacturing to implement process improvements.
• Audited manufacturing and packaging work areas to cGMPs.
• Ensured compliance with FDA, cGMP, OSHA, and HazMat requirements.
• SAP experienced (QA and Shop Floor).

Microbiologist (February 1993 to February 1994)

• Conducted microbiological testing, quality control, identification of bacteria and fungi, and water and aerobiological monitoring.

Clinical Pathology Laboratories—Austin, Texas

PRN Clinical Microbiologist (December 1993 to June 1995)

Clinical Microbiologist (May 1992 to August 1992)

• Cultured, identified, and tested antimicrobial sensitivities on a wide range of clinical specimens.
• Performed quality control, entered results into computer, and generated reports.

FarWest Medical Clinic—Austin, Texas

Microbiologist/Medical Assistant (September 1992 to February 1993)

• Performed medical assistant duties and routine microbiological set-up for physician’s practice.
• Performed routine analysis of clinical samples.

Applied Microbial Technologies—Georgetown, Texas

Environmental Microbiologist (March 1992 to May 1992)

• Identified bacteria and fungi by conventional techniques including Andersen sampling and morphology on selective and differential media.
• Analyzed nutrient and chemical levels in water and wastewater samples.

SKILLS AND KNOWLEDGE

• Strong background in morphology and biochemical activity of microorganisms as well as all staining techniques for pathogenic and non-pathogenic organisms.
• Experienced in the use of manual test kits (API) and automated systems (Biolog and Vitek) for the identification of bacteria.
• Real-world experience with both clinical and environmental aspects of microbiology; detailed knowledge of FDA Good Manufacturing Practice Regulations.
• Experienced manager/supervisor.
• Proficient in quality systems auditing and personnel management.
• Excellent communication and organizational skills; experienced in public speaking, teaching, and report writing.

PROFESSIONAL AFFILIATIONS

American Society for Microbiology (ASM)

National Registry for Microbiology (NRM)

American Society for Clinical Pathology (ASCP)

American Society for Quality (ASQ)

American Chemical Society (ACS)