Project Manager Quality

**** **** ****** **. ( Batavia, OH ***** ( ablbrb@r.postjobfree.com (

Cell: 708-***-****

Self-motivated individual with 10 years of experience

in the quality, regulatory, pharmaceutical, and clinical research

industries looking for an influential role where the ability to lead,

mentor, and utilize my problem solving skills will prove to be invaluable.

Education

Master of Health Sciences (Clinical Research Administration concentration),

2009

George Washington University, Washington, DC

Bachelor of Science in Biology, 2001

University of Illinois, Urbana, IL

Summary of QUALIFICATIONs

. Educated, trained, and experience with statistics, statistical process

control, data collection, and organization techniques.

. Able to apply the knowledge and methodologies of quality and regulatory

for increased performance and monitoring of ongoing clinical studies.

. Over 7 years of project management and process improvement experience

from process development through execution using Lean and Six Sigma

tools.

. Experienced in CAPA coordination, Continuous Improvement, Compliance,

Regulatory Affairs, Audits & Inspections, Complaints Field Alerts-

Recalls, and cGMP Training.

. Experienced in GLP, GCP, cGMP, OSHA, HIPAA, QSR and ISO Quality

Systems.

. Technical/Medical Writing skills: responsible for the generation of a

multitude of regulated documents including CRFs, clinical protocols,

510(k), PMA, IND and NDA documentation, monitoring visit reports,

validation reports, document and process change controls, proof of

concepts, standard operating procedures, process summaries, operating

principals, functional and user requirements, and other technical or

medical documents upon request.

. Computer skills: Microsoft Office (Word, PowerPoint, Access, Excel, and

Outlook), SPSS, Microsoft Visio, Microsoft Project, Microsoft

SharePoint, Statview, SPC, SAS, TrackWise, MasterControl, OpenClinica,

and MedNet

. Therapeutic areas: Endocrinology, Infectious Disease, Cardiology,

Dermatology, Respiratory, and Oncology therapeutic areas.

Professional Experience

HILL TOP RESEARCH CORPORATION - MIAMIVILLE, OH 2009 - PRESENT

Technical Writer

Independent Contractor for a Clinical Research Organization. Responsible

for writing validation documentation, standard operating procedures,

technical documents, clinical and regulatory documents.

. Organized and conducted 21 CFR Part 11 audits of the company network and

clinical software.

. Served as project manager for the validation and implementation of new

electronic data capture software.

. Tested application security features, including session expiry, book

marking, passwords and compatibility across multiple browser types and

encryption levels.

. Developed and updated Test plans, Test Matrixes, Test Scenarios, and Test

Cases.

. Audited and authored all standard operating procedures and the

Investigator Manual for the corporation.

. Prepared research protocols for medical devices and drugs according to

FDA guidelines.

. Produced ICH-compliant Integrated Clinical/Statistical Reports for

submission in the US and Canada.

Alkermes - Wilmington, OH 2008 - 2009

Compliance Associate (6 month contract)

Served as a coordinator of triage and investigation activities required for

closing clinical and commercial product complaints for a pharmaceutical

company. API(s): Rispiradone, Naltrexone,

. Developed several Microsoft Access Product Complaint databases, which

contained extensive data for over 1,000 product quality complaints and

adverse events.

. Served as project manager for product quality complaint handling.

. Routinely created metrics analysis of complaint data for trending.

. Responsible for overseeing pharmacovigilance and risk management

activities including the development of management plans, safety

strategies, and ongoing risk/benefit analysis of proprietary and

partnered products.

. Reviewed and reported adverse events in compliance with international and

domestic regulations and guidelines.

. Daily communications with all personnel from line operators to senior

management concerning technical processes, career and peer development,

and project status/roadblocks to ensure safe, efficient and uninterrupted

manufacturing of biopharmaceutical products.

Ronald Martin M.D. & Associates - Memphis, TN 2007 - 2009

Clinical Research Associate

Served as an independent contractor responsible for monitoring multiple

clinical trial sites.

. Monitored studies in phases I, II, and III. Ensured quality,

consistency, and accuracy in completion of clinical charts and case

report forms.

. Identified potential research investigators for phase I/II/III oncology,

cardiovascular, pain and diabetes.

. Resolved data discrepancies and ensured complete and accurate data by

reviewing source documents.

. Reviewed regulatory documents according to ICH/GCP guidelines and the

Code of Federal Regulations.

. Participated in quality improvement initiatives, reviewed SOPs, and

reviewed monitoring reports.

. Screened and recruited study subjects; targeted specific study and

enrollment goals; prepared study budgets.

. Responsible for the creation and delivery of presentations in regards to

personnel training, process and quality statistics, and on subjects of

technical nature with the intent to educate.

Meridian Bioscience - Cincinnati, OH 2004 - 2007

Investigations Scientist I/II

Served as a supervisor and project manager for investigating process and

product quality failures, customer complaints, and internal deviations for

a Medical Device company. Responsible for developing, writing, and

executing experimental and validation protocols (IQ/OQ/PQ) required for raw

materials, equipment, product development, investigations, and processes.

. Conducted trials site visits and served as a monitor to ensure compliance

with trial protocols.

. Managed cross-functional and interdepartmental teams to conduct

troubleshooting activities, corrective and preventative actions, and

process improvements, reducing and eliminating process downtime and

product rejects while increase efficiency and capacity.

. Served as a frontline point of contact for technical concerns and issues

regarding sophisticated, manufacturing processes, ensuring continuous

manufacturing and timely resolution of deviations. Preventing product

loss representing up to $10MM in commercial sales per batch.

. Lead the CAPA team in monthly meetings and in assuring proper

investigation through Root Cause Analysis.

. Performed risk assessments to support and defend changes to critical raw

materials.

. Developed and executed the Master Validation Plans for the manufacturing

of new medical devices as part of the Design Transfer process for each

product's Design History File (DHF).

. Developed manufacturing process flows and indentified hazardous and

critical control points (HACCP).

. Directly participated in multiple successful GMP/FDA, ISO 13485 and third-

party regulatory inspections and audits.

Naval Institute for Dental and Biomedical Research - Great Lakes, IL

2002 - 2004

Research Technician

Responsible for performing ELISA, Western Blotting, Peptide Synthesis,

Lateral Flow, Fluorescence Polarization, HPLC, Protein Labeling, and

Electrophoresis on human sera and other biological specimens for the US

Navy.

. Wrote laboratory monitoring, reporting, and standard operating

procedures.

. Designed and reviewed consent forms and CRFs; assisted with trial site

audits and testing activities to ensure compliance with the trial

protocol.

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