Quality Assurance Control

Yvonne Famorca

**** ********** ****., ***. *** O

Greensboro, NC 27410

Cell 434-***-****

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

SUMMARY

An analytical, focused, and highly skilled individual with extensive experience in pharmaceutical and cosmetic product

management/development/manufacturing, quality assurance/quality control, testing and test reporting, regulatory compliance,

equipment management and minor repair, preventive maintenance, troubleshooting, and qualification. Conducts

analyses on a wide variety of lab instrumentation and handles investigations as well as performs audits. Reviews and

approves documentation and data, while coordinating work flow for top efficiency within the workplace. With strong

instrumentation, problem solving and management skills, as well as an eye for detail and accuracy, serves as a key

contributor to success.

EXPERIENCE

PHARMACORE, INC., High Point, NC

Senior Research Associate, 2008 2/2013

Managed multiple projects as project leader and project support roles involving the production of API products in the earlier R&D stage or

full GMP scale up. Conducted method development/optimizations, validations/revalidations and transfers; ICH stability studies; reference

standard qualifications. Analyzed, reviewed, and released raw materials, in process and intermediate materials, and final products.

Trained lab personnel on analytical equipment and GMP procedures. Investigated lab out of specification results and participated in

troubleshooting events. Performed instrument calibration and maintained schedule. Operated under USFDA guidelines involving Phase I,

Phase II and some Phase III APIs, also includes pre IND stage and tox stage.

Responsible for updating and communicating with customers regarding project progress.

Prepared comprehensive method validation and stability reports.

Provided continuing support to synthetic chemists on GMP and non GMP projects.

Maintained organization and proper documentation on multiple responsibilities.

Consistently met deadlines on projects with aggressive timelines.

C.B. FLEET COMPANY, INC., Lynchburg, Virginia

Chemistry Group Leader, 2005 2008

Guided and collaborated with scientists as well as lab technicians concerning issues and problems in daily routine. Provided technical

leadership in troubleshooting events including products, manufacturing/processes, methods, and instruments. Reviewed and approved

documentation such as standard operating procedures, raw material reports, bulk in process reports, finished product reports, and stability

reports. Maintained laboratory instrument calibration program and reviewed calibration results. Evaluated and directed out of specification

investigations. Directed/reviewed method validations and lab instrument qualifications. Served in contract lab, contract manufacturer and

raw material supplier audits. Coordinated contract testing requirements. Maintained and organized various lab records. Communicated

updates on product testing and projects. Direct reports were scientists and lab technicians.

Worked closely with various groups including manufacturing and packaging, R&D, auditing, documentation control, regulatory

affairs, medical affairs, process validation, quality inspection, and CAPA groups.

Gained experience in project management.

Conducted lab manager and supervisor functions on occasions when manager and/or supervisor were out of office.

Served in rush testing of new product under limited timeline and accomplished by deadline.

Qualified nine lab instruments in three months.

Conducted troubleshooting, testing, manufacturer’s lab coordination of out of specification investigation of special interest

product.

Yvonne Famorca, Page 2

Senior Scientist, 1998 2005

Prepared validation protocols for the plant. Performed and coordinated lab validation activities such as analytical methods as well as

instrument qualifications. Executed validations for manufacturing/process equipment, cleaning processes, and packaging equipment.

Maintained stock, ordered lab supplies and coordinated with vendors. Led training of chemistry scientists and lab technicians. Set up,

transferred and evaluated procedures and analytical methods. Developed SOPs. Reviewed, and revised established procedures.

Communicated with raw material suppliers regarding COAs, specifications, and test methods. Performed maintenance and

troubleshooting of lab equipment.

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Conducted audit on contract manufacturer validation program and reviewed protocols.

Worked closely with raw material suppliers and contract labs on product issues.

Executed testing on time sensitive items.

Designed and implemented a variety of projects related to quality of raw materials and finished product processes.

Led development of company validation program and master plan.

Interpreted equipment drawings and specifications for qualification purposes.

Scientist, 1994 1998

Held responsibility in chemistry lab section of quality assurance/quality control department. Determined chemical/physical quality of raw

materials, bulk in process materials, finished products, and stability samples. Conducted, coordinated, and reported test results according

to USP/NF, BP, JP, FCC and in house procedures. Assured analyses compliance with established standards and specifications. Trained

and instructed lab technicians. Reviewed and approved submitted test results.

Detected and investigated technical quality problems. Recommended corrective actions.

Maintained laboratory equipment in good operating order by performing preventive maintenance and calibrations. Maintained

standardization of in house standards against reference standards.

Monitored laboratory procedures and practices to assure compliance with current GMP, FDA, and environmental regulatory

requirements.

Cross trained in a number microbiology lab techniques.

Performed a variety of record keeping and computer data entry of resulting data.

ADDITIONAL EXPERIENCE

C.B. FLEET COMPANY, INC., Lynchburg, Virginia, Lab Assistant. Served as assistant to scientist of research and

development department in method validations, formulation of new products and reformulation of established products,

and preparation of lab and pilot batches of new/reformulated products. Completed extensive HPLC assay development,

wet chemistry, and accelerated temperature stability studies

COSMETIC ESSENCE, INC., Roanoke, Virginia, Validation Consultant. Self employed as a contractor for a personal

care/cosmetic company. Working in the Technical Services Department, responsible for the validation of cleaning

processes of manufacturing tanks, cleaning processes of filling lines, manufacturing processes of OTC products, and

filling processes of OTC products. Prepared and executed validation protocols. Assisted the Engineering Department

on the IQ/OQ of production equipment. Coordinated validation projects and monitored progress.

SPECIAL EQUIPMENT

HPLC, UV Vis, FTIR, GC, Auto Titrator, Karl Fischer, Refractometer, Viscometer, TOC Analyzer,

Colorimeter, Melting Point Apparatus, Dissolution Apparatus, Disintegration Apparatus,

Fluorometer, Moisture Analyzer, NMR, DSC, AA, Conductivity meter, pH meter, balances, microscope

COMPUTER SKILLS

Microsoft Word, Excel, Project, Mastercontrol Documentation, Business Planning and Control System,

Quality Analyst Software, Empower, Chemstation

EDUCATION

RANDOLPH MACON WOMAN’S COLLEGE, Lynchburg, Virginia

B.A., Chemistry, Biology

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VIRGINIA COMMONWEALTH UNIVERSITY, Richmond, Virginia

Coursework toward Masters in Chemistry

AFFILIATION

American Chemical Society

Blue Ridge Chemists

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