Quality Assurance Maintenance

Marquitta A. Warren

*** ********* *****, ******, ** 27565

T: 919-***-**** /M: 919-***-****

****************@*****.***

Areas of expertise:

Expertise with a wide range of analytical instrumentation and robotic technology including: GC,

FTIR, BD LSR II Flow Cytometer, Guava, USSING Chambers, HPLC & UPLC, UV/Vis

Spectrophotometer, IC, Osmometer, Dissolution, Glove box, Viscometer, Turbidimeter, Karl Fischer,

Multimek, Oasis, and Cartesian bead picker.

Education:

Bachelor of Science General Science/Chemistry/Physics

Johnson C. Smith University Charlotte, NC

Technical Skills:

• • •

MS Word MS Outlook Lotus Notes

• • •

MS Excel ISIS Draw Agilent ChemStation

• • •

MS PowerPoint Turbochrom Water’s Millenium 32

• • •

MS Access Internet Explorer Empower 2 & 3

• •

FloJo BD Diva 5.0 and 6.0

• • •

Professional ExperiencE:

UNITED THERAPEUTICS– RTP, NC

Quality Control Chemist II 08/2011 present

• Perform analytical testing of raw materials, in process and finished product samples

• Perform analytical testing on in process, finished product and stability samples per UT

test methods and SOPs.

• Prepare SOPs, set up calibration and PM programs for the applicable equipment

identified for the analytical laboratory.

• Execute method transfer and method validation protocols as required.

• Sample incoming raw materials and components when necessary.

LABORATORY CORPORATION OF AMERICA, OTS– RTP, NC

Laboratory Supervisor Confirmations 11/2010 08/2011

• Assigns, oversees, and reviews the work of Confirmation employees.

• Directs all phases of work, quality, service, and cost; and performs tests or assays as

required.

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• Organizes day to day operations of the Confirmation lab to include; inventory, training

of employees, R & D, managing employee time cards and absence request, maintenance

of instrumentation, maintaining certification, and adherence to all SOP’s.

DUKE UNIVERSITY, CENTERS FOR AIDS RESEARCH– DURHAM, NC

Research Analyst II 4/2008 10/2010

• Performed polychromatic ICS (Intracellular Cytokine Staining) assays and acquiring

prepared samples using a BD LSRII flow cytometer in a GCLP compliant BSL 2

laboratory.

• Conjugation of monoclonal antibodies with relevant fluorophores used in flow cytometry

based assays.

• Performed daily QC and routine maintenance of BD LSRII.

• Analyzed flow cytometry data using Flow Jo software.

• Infected CEM NKR ccr5 cells with HIV pseudo virus as well as stained cells with HIV

specific monoclonal antibodies for infection monitoring.

• Worked with hazardous materials, including pathogenic viruses, radioisotopes and

chemicals.

PARION SCIENCES, INC. – DURHAM, NC

Scientist 10/2007 3/2008

• Performed primary screening assays (bioelectric measurements, drug transport, drug

durability and drug metabolism) for therapeutic use of ENaC blockers.

• Analysis by HPLC and Mass Spec. of small molecules.

• Maintained bronchial epithelial cell culture for human, canine, rodent and non human

primate.

• Ordered supplies and managing outgoing waste.

• Preparation of stock solutions for various compounds.

• Shipped material to contract research organizations.

TRIMERIS, INC. – MORRISVILLE, NC

Quality Assurance Associate 6/2007 10/2007

Compliance

• Performed periodic reviews of QA systems and implemented corrective actions when

needed.

• Evaluated changing compliance environment for trends.

• Oversaw the following systems: training records in GMP areas, standard operating

procedures and policies, archival and retention of GMP and GLP records, the Quality

Master Plan

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• Worked closely with synthetic chemistry, analytical chemistry and facilities to ensure

quality practices/procedures were established and maintained.

• Provided on going training for Trimeris in compliance with current regulatory

standards for quality.

• Worked closely with Senior Management and QA consultants to design, develop,

manage and appropriate company wide GMP training strategy, policy and program.

Scientist I 10/2001 6/2007

Analytical Sciences

• Analysis by HPLC of peptides and small molecules in a GLP/GCP laboratory.

• Routine analysis of in process, release and stability samples.

• Preparation of technical reports and Certificate of Analysis for assay.

• Provided analytical/instrumentation analysis of raw materials, bulk and finished

products including drug stability testing.

• Maintained calibration of analytical instruments and as necessary troubleshooting

and repairing instruments.

Registration Core Facility

• Overseeing all small molecule and peptide libraries for the compound

registration/distribution database.

• Development and implementation of compound registration tracking system as an

Oracle database.

• Assisting with the development of registration databases, database entry, data

integrity, as well as database maintenance.

• Revision and development of compound registration procedure and protocols.

• Development of Registration Core Facility SOP’s.

• Performed Edelhoch assays for peptides.

CHEMCODES, INC. –DURHAM, NC

Chemist 5/2000 10/2001

• Coordinated and processed solid phase chemistries by robotic bead picking and cleavage

procedures.

• Developed database and documentation procedures to record and track sample processing

status and results.

• Revision and development of company SOP’s.

• Coordinated upgrades to optimize sample processing lab operations.

• Acted as purchasing agent and inventory control for synthesis, sample processing and

analytical laboratories.

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LEINER HEALTH PRODUCTS WILSON, NC

Chemist 6/1999 4/2000

• Performed HPLC and dissolution testing on stability and production samples in

GLP/GMP laboratory as well as content uniformity testing.

• Performed calibration and maintenance on laboratory equipment and as necessary

repaired instruments.

• Performed all needed FDA regulatory documentation, data analysis and data review.

MAGELLAN LABORATORIES –MORRISVILLE, NC

Chemist 1/1999 6/1999

• Performed HPLC, dissolution, appearance, and compliance testing on tablets,

capsules, suspensions and various other samples in GLP/GMP laboratory.

• Performed all needed FDA regulatory documentation, data analysis and data review.

• Performed calibration and maintenance of various laboratory equipment.

DUKE UNIVERSITY MEDICAL CENTER DURHAM, NC

Pharmacy Tech 8/1997 1/1999

• Preparation and dispersion of various intravenous fluids such as: chemotherapy,

pediatric syringes, investigational drugs, eye drops, parenteral dosing as well as small and

large volume IV’s using proper aseptic technique.

• Trained new employees

• Entered admixture orders as well as requesting labels for patient profiles

PUBLICATIONS

“Process Development of TRI 999, a Fatty Acid Modified HIV Fusion Inhibitory Peptide.” Huyi

Zhang, Stephen Schneider, Brian L.. Bray, Paul E. Friedrich, Nicolai A. Tvermoes, Catherine Mader,

Toivo Niemi, Peter Silinski, Tony Picking, Marquitta Warren and Stephen A. Wring. Org. Process

Res. Dev., 12(1), 101 110, 2008. 10.1021/op7002198.

Process Research and Development, Analytical Chemistry, and Drug Metabolism and

Pharmacokinetics, Trimeris Inc. U.S.A

“Engineering An Experimental Platform For High Throughput Reactivity Screening.” Patrick F.

Kiser, Glenn C. Collupy, Gary M. Eichenbaum, Chad Rush, Stephan Baumann, Mark P. Kust, Michael

D. Greaves, Erik D. Frederick, Bernd Soltmann, Helen Vasina, Charles Orji, Bruno Bienfiat, John D.

Brown, John Davies, Marquitta Atkins, Jeffrey R. Lee, Eric Labow, Melissa Harp, Ann F. Goodrich,

Hilton Conyers, H. Mario Geysen. Journal of the Association for Laboratory Automation (JALA),

Volume 6, Issue 6, Pages 99 106 (1 December 2001)

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