Quality Assurance Data

OBJECTIVE

To obtain an intermediate position in Pharmaceutical Quality Control or

Quality Assurance that will utilize my skills in regulatory compliance

operations, knowledge and application of compliance requirements (21CFR

110,210,211,820), interpersonal communication, leadership and technical

competence to seek areas of improvement, increase efficiencies to meet

organizational objectives.

EDUCATION / TRAINING

Objective and results oriented technical professional with 4 years

experience in the pharmaceutical and consumer products industries.

Demonstrated and proven skills in the areas of Product Development support

and Product Launch, Risk and Crisis management, Regulatory Study

Operations, Process Improvement, Quality Systems Development and

Application and Cosmetic Safety/Risk Assessment.

Industry trained in ICH, GCP, and GMP Experienced in submitting FDA form

1572 to local and central IRB's; Involved in development of Informed

Consents and Case report forms development for Proctor and Gamble erythema

studies; Held responsibilities performing out of range data query triage

for clinical trial documentation; Attended trial meetings to discuss study

scopes and pathways for goal accomplishment; Preformed site selection for

trial participation. Coordinated sites' enrollment and ensured critical

documentation was captured in compliance with; Experienced in cGxP SOPs

development Currently involved with Product and Vendor Complaint triage:

Knowledgeable in industry standard internal and external web-based tracking

software tools for electronic logs, metrics, trending, quality and

compliance issues, and corrective and preventative action items in

accordance with cGxP standards.

See Certifications.

TECHNOLOGICAL SKILLS & SYSTEMS EXPERTISE

. 21 CFR 210/ 211

. CH E3, E5, E6, E10, Q9, Q10

. EMEA, MHRA Directives (WHO)

. Pharmacovigilance

. Pharmacopoeia/ MedWatch Reports

. FDA Form Submission 1572

. cGMP / cGCP

. SAP / PLM / SAS

. Microsoft Office Suite

. SOP Development

. Trackwise

. Clintrace

. Noetics

. Medcin

. Expert Adobe Creative Suite

. Share Point

PROFESSIONAL EXPERIENCE

Aerotek Scientific Cincinnati, OH

Contract Regulator and Compliance Associate

Clinical Research and Scientific/Pharmaceutical Industry

2005- Present

Contract employee through Aerotek Scientific staffing. Worked with CRO,

Pharmaceutical, Cosmetic and Healthcare administration for numerous high

profile companies listed with professional experience. Main duties include

compliance, regulatory, clinical data management

Alkermes, Inc.

Compliance and Quality Assurance Associate

06/2009-03/2010

Responsibilities:

. Coordinate the receipt, triage, and maintenance of all received product

complaints.

. Perform follow up activities related to product complaints with

complainants.

. Coordinate complaint investigation activities by Alkermes SME departments

to review CofA's, Stability data, chemical, microbiological, and batch

analysis .w

. Develop and finalize complaint reports and complainant communication.

. Participate in further development and continuous improvement activities

associated with the complaint handling system.

. Coordinate Product Complaint Committee(s) at all Alkermes sites.

Related Tasks:

. Coordinate triage and investigate activities required to close clinical

and commercial product complaints.

. Ensure compliance with regulatory requirements/maintain the Complaint

Management System (CMS) and all associated controlled documents and

procedures.

. Develop training materials and ensured interactive training for all

complaint approvers from each functional and approval area.

. Maintain Microsoft Access Product Complaint database, containing

extensive data for product quality complaints and adverse events.

Developed new trending report queries as necessary.

. Review batch documentation and laboratory analysis reports supporting the

manufacture of finished goods

. Batch Record Reviews Included:

. Fill Weight Data Sheets/ Fill Event Log

. Vial inspection

. AQL Review

. Deviations/Excursions

. Shipping Documentation

. Storage Temperature Data

. Stability

. Create metric analysis of complaint data for trending.

. Evaluated manufacturing, labeling and promotional material changes for

regulatory impact.

. Prepared response to corrective and preventative action letters and other

agency requests.

. Review adverse event reports in compliance with international and

domestic regulations and guidelines.

. Participate in compliance activities, such as internal audits, FDA and

Notified Body audits, complaint handling and vendor audits.

. Ensured ongoing compliance with customer quality requirements by

coordinating annual product testing and facility audits.

Kao Brands

Product Safety Scientist

06/2008-12/2008

Responsibilities:

. Risk analysis of Prop 65 contaminants extracted from raw material MSDS

sheets and supporting product safety documentation for Kao Brands

products worldwide.

. Responsible for preparation and management of product trace safety

assessment in regards to raw material trace elements

. Prepared Review of Analysis Reports for Safety Counsel.

. SOPs: Prop 65 Risk Analyses:

. Review raw material contaminant data for the PLM/SAP platform and

Uploaded data related t MSDS trace elements into pro65 analysis excel

calculation worktable to asses levels.

. Formulate data to calculate NSRLs (No Significant Risk Level) for

carcinogens and MADLs (Maximum Daily Levels) for chemicals that cause

reproductive toxicity to determine whether formulation mandates

modification due to exposures to listed chemicals.

. Prepare chemical trace breakdowns for all ingredients included in final

product formulation to the billionth for Prop 65 analysis, title 212 CCR.

. Managed MS Access format Prop65 Dbase, including design of queries

. Developed metrics for Prop65 carcinogens formulated calculations to the

billionth and applied of appropriate analysis refinement factors to

validate clinical study ingredients against the acceptable levels of

cGXP.

. Identified emerging raw material Prop65 issues in conjunction with team

members for prototype formulas

. Worked in conjunction with Product Development scientists and cross-

functionality with Regulatory Affairs in management of raw material

information.

. Safety Study Database Controller:

. Entered and managed information into the Access 200 format Bridging

Safety Study Dbase

. Created queries to populate Bridging Safety Study Reports, and wrote

subsequent reports

. Product Safety Summary Report generation from CRO Executive Summary

Safety Clearances

First Group America Cincinnati, OH

Project Coordinator assignment

02/2009-06/2008

Responsibilities:

. Supplier trend analysis using MS Access, understanding and documenting

business requirements for purchases, researching the supply market, trade

magazines, research organizations for alternate sources of supply on

global basis and collating data

. Pulled samples of invoices from selected vendors and built a spend

database where required

. Produced individual plans and managed day to day and week to week

activities to that plan

Procter and Gamble Cincinnati, OH

Clinical Data Management Specialist

02/2008-12/2008

Responsibilities:

. Assisted clinical Bio-statisticians in collecting and reporting data from

clinical studies to compare absorbency of Pampers to the main competitor

Huggies to update Marketing documentation for accumulated research data

. Responsibilities included: creating file specs and annotated case report

forms for the study, creating data reports and performing quality

analysis of data specs, querying discrepancies in data ranges back to the

study clinic and laboratories for modification, creating study summary

reports identifying key pieces of data needed, defined SAS data sets to

upload electronic data and generate data listings and frequencies for Bio-

statistician reviews and ran SAS programs to perform data integrity

checks

MAbTech Cincinnati, OH

Biotech Marketing Associate

12/2007-02/2008

Responsibilities:

. MAbTech provides a wide range of high quality ELISA and ELISpot kits for

analysis of cytokines and other immunological effecter molecules in a

variety of species. MAbtech provides antibodies as separate reagents for

other applications including Flow Cytometry and Immunocytochemistry.

. Assisted in marketing of monoclonal antibodies to major colleges

including Cambridge, Harvard, and MIT for participation in various

immunological assays in effort to procure effective responses in

eradicating various diseases in research including certain cancer and

tuberculosis protocols.

. Researched appropriate Departments globally, prepared marketing

collateral, coordinated efforts in exhibitions and scientific seminars

West End Health Center Cincinnati, OH

Unit Coordinator

08/2007-12/2007

Responsibilities:

. Performed insurance verification and data updates in Medical Manager

Software

. Prepared encounter sheets for physician reviews and originated documents

to note visit specifics for services rendered at facility

. Performed statistical updates for physician licensure with the Ohio

Department of Information and the DEA licensing web interface

Aon Risk Management Cincinnati, OH

Project Researcher / Presentation Developer

02/2007-07/2007

Responsibilities:

. Researched potential new prospect customers using the department of

Economic Development and United States Census data to build reports

directing new business development for health and welfare division of Aon

Risk Services, Inc

. Documented indexing of informed consents and case report forms for a

military conducted clinical trial, protocol study of hematology of the

West Nile Virus emphasis on hematology

. Phase II presentation development for proposals and report development

for project phases

Kendle International Cincinnati, OH

Trial Regulator and Project Specialist

12/2005-08/2006

. Responsibilities:

. Phase IV site management: Novo Nordisk / Johnson and Johnson and study

kick off participation

. Responsibilities included: reviewing protocol requirements for

investigator and patient participation, collaboration of SOP design

conducive to trial scope, development of informed consents for

recruitment, collection of regulatory documentation, IRB submissions,

release of pharmaceutical devices and drug to sites, data tracking of

case report forms, queries on out of range lab data and tracking of drug

usage and reports of fluctuations; inconsistencies and adverse events.

. Collaborated with other functional areas to obtain documentation for

regulatory purposes, sought expert advice and technical support as

required, and ensure accuracy and completeness of all information.

. Prepared regulatory documentation such as device listings, certificates

to foreign governments and Canadian medical device licensing.

. Assisted with preparation and submission of FDA pre-market notifications

(510 and 1572) and preparation of final product package marketing to FDA

NDA submissions.

. Assembled, prepared and submitted original registrations, amendments,

supplements, variations, maintenance reports and other documents to

regulatory agencies in line with local regulatory requirements and

guidelines.

. Assisted in preparation of regulatory strategies and identification of

regulatory requirements for submissions to insure the efficient approval

and registration of products.

. Prepared outlines, summaries, status reports, graphs, charts, tables and

other metrics for track and trend analysis.

. Prepared letters to file; technical files for the sponsor and IRB, and

other submissions/materials for global regulatory agencies as required.

John Wiley and Sons Publishing

Design9 Cincinnati, OH

Medical and Biological Textbook Illustrator

09/1997-05/2007

Responsibilities:

. Specialized in molecular cell biology illustration emphasizing

understandings of chemical, microbiologic, and anatomical processes.

. Concentrated visual communication molecular and chemical states of being,

their reactions and conversions in visual terms

. Molecular Biological and medical procedures included but not limited to;

meiosis-mitosis,

. Participated in daily interaction with scientific authors to develop

designs that convey the information

. Responsible for the collection of scientific concepts, review of the

concepts and research of anatomical environments and medical procedures

. Pepared concept design for author review, revisions and production for

both print and supplemental CD

Design9 dba

1997-2002

President / CEO Cincinnati, OH

Scientific and consumer goods advertising, business project management and

visual communications assistance areas; focused on strategic planning,

marketing, retail sales, outsourcing, maximum profit, business development,

partnership development, new market identification, exports markets,

modernization, promotions.

EDUCATION

Columbus College of Art and Design

Scientific and Medical Illustration

Bachelor of Arts

Focus: Medical/Scientific Illustration; Anatomy/Physiology/Microbiology)

Cincinnati Art Academy Cincinnati, OH

G.P.A. 3.8/4.0

Cum Laude

AFFILIATIONS / CERTIFICATIONS / PUBLICATIONS

Biotech & Pharma Professionals Network

Communication Arts

RAPS

Currently studying for RAC US certification scheduled April 2011

Textbooks:

Karp:

Cell and Molecular Biology: Concepts and Experiments, 2nd Edition

John Wiley and Sons, 1998

Karp:

Cell and Molecular Biology: Concepts and Experiments, 3rd Edition

John Wiley and Sons, 1999

Bioinquiry: Making Connections in Biology Learning System 1.2

Server, Pruit, Underwood

John Wiley and Sons, 2000

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