Quality Control

objective:

To obtain a position that will allow me to use my scientific knowledge and

quality control experience to design, develop, and improve the quality of

pharmaceutical and biotechnology products and processes.

Education:

. North Carolina Agricultural & Technical State University, Greensboro, NC,

June 1996

Bachelor of Science: Industrial Engineering

Technical Skills:

. 11 years of experience in Quality Control

. Microsoft Office Word, Excel, Outlook, Power Point, Publisher and Access;

Fortran; Microsoft Networking; AutoCAD; Agilent Cerity Chromatography

(CDS) software; Chemstation, Empower 3 software, LIMS (Labware), and

Minitab

. MSDS (Materials Safety Data Sheets), quality audits, quality inspector,

JIT (Just in Time), ISO (International organization for Standardization),

TQM (Total Quality Management), SPC (Statistical Process Control) and

time studies

. Experience in coatings, oil exploration, pharmaceutical/biotechnology,

plastics, wastewater and cosmetics

. Completed Yellow Belt Certification- Lean Six Sigma

Employment:

April 2012- Present

Fujifilm Diosynth Biotechnologies, U.S.A., Inc., Research Triangle Park, NC

Senior QC Associate

. Independently schedule, plan, and execute chemistry testing/quality

support functions to support batch release according to established

scheduling and communication tools.

. Perform routine testing in support of product stability; conducted non-

routine testing such as reference, assay (API and BI), UFDF, Bulk Drug

Substance, Bulk Drug Product, reagent qualifications, technical transfer

of assays, method validation (according to ICH guidelines), and internal

and sponsor investigations; performed Protein Concentration (UV-Vis)

tests, Purity assays (IEX-HPLC, AEX-HPLC, SEC-HPLC, and RP-HPLC), and

quality tests (pH, appearance, osmolality, TOC, and conductivity).

. Initiate statistical review of relevant data e.g. product/complaint

trends, laboratory test results, stability profiles, etc. as data is

reviewed.

. Initiate PR's (progress reports) for invalid assays, LIR (lab

investigation reports), OOS (out of specification) results in the Quest

Management System.

. Participates in departmental safety inspections, and other internal

quality audits,

. Communicate effectively using visible management tools, such as task

assignments and scheduling boards.

. Autoclave hazardous waste material from the QC Laboratory.

. Troubleshoot issues with 1100 series Agilent HPLC Instrumentation.

. Assure accurate and compliant documentation of cGMP activities in the

laboratory area

. Support testing for the laboratory operations during off-hours in support

of the established supply schedules as needed.

. Assure that assigned tasks are completed according to establishes

schedules and procedures in a (RFT) Right First Time, high throughput

environment.

. Purchase supplies as necessary

February 2011- April 2012

Diosynth Biotechnology, a subsidiary of Merck & Co. Inc, Research Triangle

Park, NC

Senior QC Raw Materials Associate

. Performed routine analytical testing of non-compendial and compendial raw

materials (USP, JP, EP), using analytical instruments (i.e, HPLC, UV-Vis,

automatic titrator, FT-IR, polarimeter, KF).

. Reviewed associates' data packets for documentation and calculations.

. Performed wet Chemistry tests on raw materials (i.e., LOD, ROI,

appearance, pH, titration, etc.). Prepared standard and sample solutions

as required by the test methods or monograph.

. Performed light metrology on 1100 series Agilent HPLC Instrumentation.

. Prepared a Certificate of Analysis for raw materials.

. Performed assigned projects and write summary reports.

. Assisted in ordering supplies.

. Performed weekly and monthly laboratory duties.

. Wrote SOP's (standard operating procedures) for new laboratory

instrumentation.

. Wrote and revised STM's (standard test methods)

June 2007- January 2011

Diosynth Biotechnology, a subsidiary of Merck & Co. Inc, Research Triangle

Park, NC

Senior QC Associate

. Ensured product conformance by performing in-process and release testing,

supporting process validation and providing technical expertise.

. Performed routine testing in support of product stability; conducted non-

routine testing such as reference, assay (API and BI), reagent

qualifications, technical transfer of assays, method validation

(according to ICH guidelines), and internal and sponsor investigations;

performed Protein Concentration (Bradford, UV-Vis and Lowry methods)

tests, Purity assays (IEX-HPLC, SEC-HPLC and RP-HPLC), Capillary

Electrophoresis and quality tests (pH, appearance, osmolality and

conductivity).

. Reviewed associates' data packets for documentation and calculations.

. Initiated PR's (progress reports) for invalid assays, LIR (lab

investigation reports), OOS (out of specification) results in the Quest

Management System.

. Autoclaved hazardous waste material from the QC Laboratory.

. Performed light metrology on 1100 series Agilent HPLC Instrumentation.

March 2007- May 2007

ECOFLO, Inc. (On Assignment Lab Support), Greensboro, NC

Lab Technician

. Ran analysis on hazardous waste products, using Karl Fischer titration,

pH meter, calorimeter, etc.

. Tested for PCB's on hazardous waste products using GC (gas

chromatography).

August 2005- February 2007

Burt's Bees, Inc., Durham, NC

Junior Analytical Chemist

. Sampled and tested raw materials, bulk and finished products using a

penetrometer, viscometer and pH meter; released all materials and

products meeting quality specifications.

. Reported out-of-specification results to the Quality Resources department

manager and Quality Resources lab supervisor; evaluated the color shade

of color cosmetics products and worked with Batching Department personnel

in making corrective changes.

. Assisted the process engineer and batching manager in auditing assigned

practices and methodologies to ensure efficient and accurate amounts of

mixing ingredients; ensured proper updates into Macola Information

Inventory Control logs to accurately reflect quarantined, released and

rejected materials.

. Performed quality audits as needed and as assigned, completed appropriate

product documentation onto history cards, and observed and ensured the

maintenance of all applicable GLP (Good Laboratory Practices) and GMP

(Good Manufacturing Practices) guidelines.

. Assisted in writing SOP's (standard operating procedures) for new and

existing tests.

. Assisted in writing bulk specifications for new and existing products.

September 1999 - July 2005

Chemol Company, Inc., Greensboro, NC

Quality Control Chemist & MSDS Coordinator

. Ran analysis on raw and finished products as well as bench testing.

. Used the pH meter to check water samples; the tintometer and colorimeter

to check color on raw materials; Karl Fischer titration to check moisture

in products; the viscometer to check viscosity of products; GC to run

fatty acid profiles.

. Provided timely results to the shift supervisor to keep production

continuous; inspected packages, labeled and placarded products during all

phases of loading before shipping.

. Wrote user friendly test methods, updated records of analysis, assisted

in problem solving, organized MSDS (materials safety data sheets) and

assisted Research and Development with projects.

June 1999 - September 1999

Carolina Plastics, Greensboro, NC

Shift Supervisor

. Effectively provided and maintained training records for production

workers, maintained identification and proper routing of products through

the manufacturing process, performed preventive maintenance on machines,

and controlled and monitored the productivity and quality of products.

. Assigned and directed work and assured proper materials were available.

May 1997 - May 1999

Banner Pharmacaps, High Point, NC

Gel Technician

. Performed quality checks on finished products, via viscometer and

dispensed gelatin into tanks.

. Regulated temperature of gelatin and weighed dry powdered dyes.

. Processed the production of gelatin using the computer.

REFERENCES:

Available upon request

Contact this candidate