Quality Control Assurance

Brian W. Costello

** ***** **., *** * Delmar, NY 12054

518-***-**** *********@*******.***

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Summary of Qualifications:

• Dedicated quality control Microbiologist with 6 years experience working in a cGMP facility.

• In depth knowledge of laboratory methodologies and equipment.

• Experienced applying good aseptic technique in a clean room environment

• Strong computer proficiencies, with excellent communication skills.

Education

STATE UNIVERSITY OF NEW YORK AT ALBANY, Albany, NY

Completed 27 credits toward Masters of Science in Forensic Molecular Biology

Bachelor of Science in Biology 2001

Mohawk Valley Community College, Utica, NY

Associates Degree in Life Sciences 1999

Professional Experience:

Stiefel, A GSK Company: Oak Hill, NY 2004 – Present

Senior Analyst, Microbiology Department

• Authored seven test methods based on USP chapters <61> and <62>.

• Performed 50 + method validations on topical product formulations and in-house raw materials. This

validation work was critical in reducing the cycle time for the release of batches.

• Trained three analysts on performing test methods, including total aerobic microbial count, total mold and

yeast count, and the tests for specified microorganisms.

• Proficient in the testing of purified water systems and microbial swab testing of cGMP rooms and product

contact surfaces. This environmental monitoring was essential to the quality control of our batches.

• Performed Antimicrobial Effectiveness Testing on twenty five topical products in different stages of stability

studies.

• Qualified laboratory equipment including six precision balances, and two autoclaves which were important to

the proper functioning of the laboratory.

• For three years, maintained the working stock of thirteen ATCC organisms, streaking new passages once

every two weeks to comply with USP guidelines.

• In February of 2008 was put in charge of training two analysts on the new USP growth promoting guidelines

for media preparation.

• Contributed to a quality assurance committee that wrote and updated departmental SOP’s and work

instructions.

• Attended a training seminar on the use of the Micro Pro, a rapid microbial testing instrument. Currently

working on the performance qualification and use of the Micro Pro instrument for the testing of products.

Using this instrument will reduce the cycle times for assignments from five days down to two days.

Stiefel, A GSK Company: Oak Hill, NY 2002-2004

Associate, Stability Group

• Executed stability studies performed on topical products, such as DUAC Gel. Compiled laboratory test results

from stability studies into reports using LIMS. These reports helped regulatory personnel establish expiration

dates for our products.

SUNY ALBANY: Albany, NY 1999 – 2002

Laboratory Assistant

• In charge of maintaining adequate levels of laboratory supplies for various lab classes.

Computer Skills:

• Microsoft Office Suite, Lotus Notes, Adobe Acrobat, and LIMS.

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