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Quality Control Assurance

Location:
Denver, CO
Posted:
January 08, 2014

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Resume:

Bradley T. Beres

Professional Experience

Colorado Serum Company - Denver, CO May 2012 - Present

Senior Quality Analyst

. Conduct Chemistry and Microbiology assays including ELISA, sterility,

mycoplasma, pH, formaldehyde, moisture, and phenol testing on

vaccines, blood samples, and active ingredients

. Part of team that implemented Endotoxin testing on final products

within QC laboratories

. Work within R&D to develop and improve new and existing assays

specifically ELISA and RID tests

. Audit assays, systems, and procedures, investigate and identify

problem areas and work with Quality Assurance in implementing CAPA's

. Schedule and perform stability testing on final products

Merial Limited - Athens, GA

Senior Quality Control Technician

August 2010 - April 2012

. Conduct and assist supervisors in design and execution of problem

solving protocols using event analyses, and other tools to determine

root cause

. Conduct monthly Assay, Technician, and HSE audits and implement

corrective actions

. Maintain online chemical inventory and dispose of laboratory hazardous

materials

. Assist management in monitoring KPI's and implementing actions to meet

goals

. Develop relationships with R&D to transfer and develop new assays

. Experience validating new assays and reagents within Quality Control

. Train incoming and existing employees on assays and SOP's

. Writing and / or updating controlled methods, data captures, and

manufacturing records

. Experience working with and understanding regulatory requirements

(9CFR)

. Implemented a supply stocking / ordering system to ensure supplies are

on hand as needed

Quality Control Technician

October 2007 - August 2010

. Extensive mammalian cell line management work

. Virology assays including titrating viruses, COFAL testing, and

immunoscreens

. Immunochemistry assays such as ELISA's, UV Peaks, and Glycoprotein

analyses

. Microbiology tests such as sterility, mycoplasma, and contaminant

identification

. Knowledge to work safely in a Biosafety Level 2 (BSL2) Laboratory

. Vaccinating dogs and cats, and obtaining blood samples for further

testing

. Successfully completed training in LEAN manufacturing

. Part of team that facilitated and implemented LEAN in the quality

control department

. Vaccinated and eligible to work with rabies virus and smallpox

Bradley T. Beres

Resume

Page 2

Education

University of Georgia

Bachelor of Science in Forest Resources

Graduated: May 2007 Cum Laude

Volunteer Experience

Bear Hollow Wildlife Trail February 2004 - May 2004

. Responsible for food preparation, cage cleaning, and feeding of the

animals.

. Other duties include providing the public with information on Zoo day

events and assisting with outreach programs as needed.

Skills Gained Through Work Experience

. Light and FA microscopy

. Fluorescent staining

. Aseptic Technique

. Cell Line Management

. LEAN Manufacturing

. Dilutions

. pH meter use

. Media Preparation

. Viral Titrations / Culture

. Care and Use of Spectrophotometer

. Team player

. Dependable

Professional Organizations

. Trout Unlimited

. The Wildlife Society

. University of Ga. Herpetological Society

Computer Skills

. LIMS -Laboratory Information Management Systems

. KC Junior Software

. Gen5 Software

. Microsoft Office

. Scientific Literature Searches

627 Walden Circle % Apt. 203 % Boulder, CO 80305

678-***-**** % ****.*****@*****.***

Summary

Quality control professional in the bio-pharmaceutical industry with a

diverse range of skills including the ability to lead? Apt. 203 ?

Boulder, CO 80305

678-***-**** ? ****.*****@*****.***

Summary

Quality control professional in the bio-pharmaceutical industry with a

diverse range of skills including the ability to lead, scientific

integrity, and focus on the customer. Ability to work in a government

regulated environment under cGMP guidelines. Strengths in immunochemistry,

virology and microbiology assays. Capable of conducting audits,

identifying and investigating problems, and determining CAPA's utilizing

event analyses and root cause analyses. Experienced in writing and

updating standard operating procedures and controlled methodologies.

Capable of working with QA and continuous improvement personnel to maintain

a high standard of quality.



Contact this candidate