Kirby I. Montgomery

** ********* *****, *.*. Box 291

Taneytown, MD 21787

Telephone: 410-***-****

E-Mail: acf8ak@r.postjobfree.com

* U.S. Military Veteran *

Employment Objective:

Full-Time Position in Quality Assurance, Quality Management, Quality

Control using the benefits of extensive experience in the Laboratory and Pharmaceutical fields.

Professional Experience:

Laboratory Inspector (Surveyor): Commission on Office Laboratory

Accreditation, Columbia, MD. 1995 - 2014.

Performed Laboratory Inspections (Audits) for regulatory compliance using

the same methodology as Laboratory Management and Technical Consultants, and using software based upon the Quality Management System (QMS) format (including Quality Assurance (QA)). This was performed over a nineteen (19) year period and encompassed all fifty (50) states.Reports included standard reportsand ones with recommendations requiring further consideration.Performed administrative tasks,

conducted training of Surveyors using the aforementioned (QMS) formatin all areas, including Quality Assurance (QA). Assisted in International Standards for Organization

(ISO) Audits. Assisted in computer troubleshooting and software implementation. Evaluated papers for submission and review in the NCCLS/CLSI (National Committee for Clinical Laboratory Standards/Clinical Laboratory Standards Institute) format, reviewed and revised procedures and criteria, and performed Customer Service duties. Provided technical consultation in Microbiology.

Completed the Quality Management Systems (QMS) Program online with High

Honors. Also completed the Laboratory Director Certification Program online and qualified to direct a Moderate Complexity Laboratory under CLIA. This program was also completed with High Honors.

Received a Special Achievement Award in 2002 and several additional awards

during 2010-2012.

Served on both Surveyor and Scheduling Task Forces to improve the audit

quality, efficiency and productivity.

Assistant Supervisor: Immunochemistry, Union Memorial Hospital,

Baltimore, MD. 1993 - 1995.

Supervised personnel, reviewed Quality Control, Quality Assurance, and other documentation, wrote and revised procedures in all areas, performed administrative duties,

performed ELISA, Serological,MEIA/FPIA analyses (Abbott AXSYM, TDX, and IMX), Electrophoresis, RIA testing, and IFA/DFA screens.

Assistant Supervisor: Immunochemistry, Central Laboratories-Assoc.

Maryland Pathologists, Div. Of Metpath/Corning Clinical Laboratories,

Timonium, MD. 1991 - 1993.

Supervised personnel, reviewed Quality Control, Quality Assurance, and

other documentation, conducted training sessions, wrote and revised procedures, and performed Serological, ELISA, and RIA testing. Provided consultation in Immunology.

Senior Technologist: Hematology/Chemistry Stat Laboratory (same

location). Performed testing on Coulter STKR, ACL (Coagulation), Baxter

Stratus, Roche RA 1000, FARA, MIRA, and Hitachi systems.

Medical Technologist: Dept. of Medical Microbiology, Laboratory

Medicine, Johns Hopkins Hospital, 600 N. Wolfe Street, Baltimore, MD.

1991.

Performed Microbiological and Serological procedures, ELISA, Gene Probes,

Abbott IMX and other

competitive binding assays, Western Blots, and IFA/DFA screens.

Microbiology Supervisor: Microbiology Dept., Q.C. Laboratory, Barre-

National Pharmaceuticals, Inc., Baltimore, MD. 1988 - 1991.

Note: Pharmaceutical Company produced primarily Generic Pharmaceuticals.

Supervised personnel, reviewed Quality Control (QC), Quality Assurance (QA)

and other documentation.Provided consultation and recommendations regarding the area of

Microbiology. Performed Audits of each step of the process of Pharmaceuticals, including Audits of manufacturing and production throughout the facility.

Performed Pharmaceutical and Environmental Microbiological testing

including microorganism identification and assays of antibiotics and antimicrobial

substances). Performed Quality Control of all Components, of the final Pharmaceutical product, and its subsequent potency and stability.

Performed administrative duties, insured Laboratory testing was in

compliance with Good Manufacturing Practices (GMP), assisted in planning, expansion, and design of the new Laboratory, updated Dept. with automation and computerization (including Image Analysis and automated Media preparation), wrote and revised procedures in all areas (including QC & QA), trained personnel, and accepted full duties as Supervisor on resignation of predecessor.

Received Quality Award, 1991.

Medical Technologist: Dept. of Clinical Microbiology and Infectious

Disease, University of MD Cancer Center, Baltimore, MD. 1984 - 1988.

Performed procedures in Clinical Microbiology and Serology,

Immunofluorescent Assays, and instructed Medical Technology and Medical School Students on rotation. Assisted in ongoing research projects.

Achieved highest productivity for Dept. in 1987.

Medical Technologist: Microbiology Section, Dept. of Clinical

Pathology, Provident Hospital, Inc., Baltimore, MD. 1983 - 1984.

Performed procedures in Clinical Microbiology and Serology.

Medical Technologist: Dept. of Laboratory Medicine, Southern Chester

County Medical Center, West Grove, PA. 1980 - 1982.

Performed procedures in Serology, Parasitology, Hematology,

Immunohematology, Clinical Chemistry,and Clinical Microscopy. Assisted in Bacteriology.

Medical Laboratory Specialist: US Army, Headquarters, 15th Medical Bn.,

First Cavalry Div., III Corps, Fort Hood, TX. 1978 - 1980.

Served in Darnall Army Hospital (500-Bed Facility) in Hematology,

Immunohematology, Clinical Chemistry, and Clinical Microscopy.

Served as sole Serodiagnostician for the Division Office of Preventive

Medicine.

Received several Letters of Appreciation and an Honorable Discharge upon

completion of service.

Professional Education:

Graduate School: University of Maryland University College. Currently

enrolled in my final course of a

Graduate Certificate Program (Masters-Level) in Biosecurity & Biodefense.

2013-present. 4.0 (A)average.

Bachelor of Science (Biological Science): University of the State of

New York, Albany, NY (Ext.). 1982.

Associate in Science (Liberal Arts and Sciences): University of the

State of New York, Albany, NY (Ext.). 1981.

Diploma in Medical Laboratory Technology: Academy of Health

Sciences/Baylor University Parallel Program., Waco, TX. 1977-1978.

Professional Certifications:

Technologist in Microbiology (M(ASCP)) American Society of Clinical

Pathologists. 07/2005. Recertified in July, 2014.

Clinical Laboratory Scientist in Microbiology (CLS-M(NCA)) National

Certification Agency for Medical Laboratory Personnel (NCA). 11/1991.

Technologist in Hematology (H(ASCP)) American Society of Clinical

Pathologists. 08/1986.

Technologist in Immunology (I(ASCP)) American Society of Clinical

Pathologists. 08/1985.

Registered Microbiologist (RM(AAM-NRM-ASM)). The National Registry of

the American Academy of Microbiology, American Society for Microbiology.

01/1984.

Specialist Certifications:

Pathogenic Bacteriology

Parasitology

Food, Dairy, and Sanitation Microbiology

Medical Technologist (MT(ASCP)) American Society of Clinical

Pathologists. 08/1983.

Awards:

Cambridge Who's Who Award for Excellence, 2010.

Continuing Education:

Completed the Stratford Career Institute Forensic Science Program

online. Graduated with High Honors, 2013.

Completed the COLA Lab University Quality Management Systems (QMS)

Program online. Graduated with High Honors, 2010.

Completed the Stratford Career Institute Business Management Diploma

Program online. Graduated with High Honors. 2007.

Completed COLA Lab University Laboratory Director Certification Course

online. Graduated with High Honors, 2006.

Microbiological Quality Assurance of Biological and Pharmaceutical

Products. American Society for Microbiology. 1990.

First-Line Management Supervisory Skills Certificate Program, Barre-

National, Inc. 1998.

Personal and Small Business Computing. Catonsville Community College.

1988.

Introductory Management. E.T.S. Princeton. 1988.

Monoclonal Antibodies Practical Workshop. Hood College. Workshop

included ELISA, EIA, and Hybridoma-Monoclonal Antibody/Vaccine production.

1985.

Developing Supervisory Skills, Catonsville Community College. 1984.

Advances in Medical Microbiology and Diagnostic Immunology, Johns

Hopkins University School of Medicine. 1982.

References:

Cole Richardson, PhD

FDA Consultant

Medical Device Engineering & Regulation

6205 Pontiac Street

Berwyn Heights, MD 20740

301-***-****

Kathy Richardson, MT(ASCP)

Consulting Supervisor for Physicians Office Laboratories

COLA Technical Advisor

6205 Pontiac Street

Berwyn Heights, MD 20740

301-***-****

Contact this candidate