Summary:

Solid team member/leader with management skills which allow for various studies/assignments to be completed.

Detail oriented technician, safety officer, and efficiency developer that permitted for little to no protocol deviations or work related injuries.

Education:

PathWise

Technical Writing (Focus on Investigations)

Academy of Applied Pharmaceutical Sciences

Introduction to Pharmaceutical Auditing

University of Michigan

Ann Arbor, MI

● Coursework in English, Chemistry, Calculus, and Biology completed

2003

Cass Tech High School

Detroit, MI

● Obtained Diploma

Experience:

1999

For Aerotek 05/2014-01/2015 For Sun Pharmaceuticals 02/2015-12/2015 Nostrum Labs 01/16- 02/16

Quality Assurance Tech. 1

●Safety Marshal

●In training to approve qualification protocols, and

investigations.

●Liaison between Quality Assurance, Quality Control,

and Production/Engineering

●Review and Approve Quality Control investigations, Microbiology

Contract Analysis, Temp./humidity records

●Reviewing MBR/MPR, and other GMP documents

●Conducting investigations

●Ensuring GMP’S, procedures and practices are followed

●GMP Audits of Quality Control, Databases, Production, etc.

●System generation and/or updates

Bryan, OH

The PIC Group

Toledo, OH

Quality Inspector (On Call)

05/2013-06/2014

●Routinely placed in supervisory role in absence of lead hand

●Visually inspect or manually rework different automotive parts and ensure conformity to specifications

●Contribute to team effort by accomplishing goals as needed

●Requested by multiple suppliers for projects

University of Michigan Hospital Ann Arbor, MI

Lab Tech./Research Assoc./Clinical Research Assoc./Autopsy Tech. 06/2002-07/2012

●Worked as part of the Cancer Prevention Research Group where we researched NSAID’s through various means

●Supervised, scheduled, taught, and interacted with 20 different employees at various levels that were tasked to multiple studies

●Researched and developed HPLC assays according to FDA regulations

●Troubleshoot, performed maintenance and supervised undergrad/post doc students on three different HPLCs in two different labs on multiple studies

●During extended HPLC runs, performed stability tests to ensure sample integrity

●Responsible for subject recruitment, tracking and vendor selection and negotiation

●Shipped, received, tracked, and managed data quality and biological samples from twenty research sites, national and international

●Amended protocols, SOP’s, flyers, and CRF’s

●Occasionally drew blood from volunteers, usually per assignment

●Harvested plasma, serum, DNA, and lymphocytes in a joint study with the CDC

●Executed enforcement of University of Michigan Hospital, GCP, and federal safety policies as lab fire safety leader and designated safety officer

●Efficiently executed space allocation and equipment usage

●Performed autopsies for hospital and Washtenaw County Medical Examiner

●Trained in the collection of bodily fluids and tissues for toxicology, body/organ weight and measurements and preservation for gross-specimen conference

●Administrated cremation/disposal of specimens, data collection and entry as well as general care of the morgue

Accolades:

●Released to perform GMP audits and run the majority of the internal audit program including drafting and maintaining the internal audit schedule and regenerating the system

●Conducted and reviewed investigations on behalf of Quality Assurance Management.

●Was promoted three times in the oncology department, the first time after four months as a part time lab tech

●My work was said to be that of a master’s degree level employee by the primary investigator in my promotion letter to become a research associate

●Every audit was passed with minimal to minor infractions/deviations in the lab

●During my tenure, I held four different titles in two different departments

●The retiring morgue supervisor approved me to the current administration for her position

Publications:

“Ultra-low Flow Liquid Chromatography Assay with Ultraviolet (UV) Detection for Piperine Quantitation in Human Plasma”

Madhuri Kakarala, Shiv Kumar Dubey, Malloree Tarnowski, Connie Cheng, Samadhi Liyanage, Terrence Strawder, Karim Tazi, Ananda Sen, Zora Djuric and Dean E. Brenner J. Agric. Food Chem 58(11):6594-6599 (2010) PMID 20465211

Acknowledgments

“A randomized feasibility trial of brief telephone counseling to increase fruit and vegetable intakes”

Zora Djuric,* Jennifer S. Ellsworth, Jianwei Ren, Ananda Sen, and Mack T. Ruffin, IV Prev Med. 2010 May–Jun; 50(5-6): 265–271. PMCID: PMC2904076

“Obesity, Stem Cells and Cancer”

Madhuri Kakarala MD, PhD. Presentation at The University of Michigan 10/2011

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