Project Manager Quality Assurance

MARVELYN BROWN

*** ******** **. • Dayton, OH ****7 • ********@*****.***

Cell: 937-***-**** • LinkedIn: http://www.linkedin.com/in/marvelynbrown

Accomplished professional with experience in business analysis, quality assurance and technical writing.

Background includes auditing, project management, operations support and analysis. Industries include

biotech, pharmaceutical, mortgage banking, information technology and consumer goods.

COMPUTER APPLICATIONS

Microsoft Office (Word, Outlook, Access, PowerPoint, and Excel), MS Project, Adobe Photoshop, Illustrator

Dreamweaver, Fireworks, Peregrine Systems Service Center Helpdesk Software, HTML, CSS, Trackwise

Discrepancy Reporting System, SQL, IBM SCORE (Solution for Compliance in a Regulated Environment)

Electronic Document Management System (EDMS).

WORK HISTORY

U.S. Food and Drug Administration Consumer Safety Inspector 1990 – 1997

National City Mortgage (now PNC) Business Analyst/Project Manager 1997 – 2003

Alkermes Controlled Therapeutics Quality Systems Specialist 2003 – 2006

Talecris Plasma Resources Quality Supervisor 2008 – 2009

U.S. Census Bureau Crew Leader 2010 – 2010

Cintas Corporation Accts Receivable 2010 - 2012

INDUSTRY EXPERIENCE

TALECRIS PLASMA RESOURCES - Dayton, Ohio 2/2008 to 2/2009

Quality Supervisor

Recruited to monitor and evaluate quality for a company that specializes in the collection of human plasma,

used to produce critical care treatments for people with life-threatening disorders.

Responsible for quality review and approval of center operations, specifically the collection, processing and

release of human plasma. Performed audits, reviews and inspections to monitor manufacturing activities and

quality controls to verify that data was complete and accurate. Ensured that standard operating procedures

(SOPs) were followed. Utilized exceptions reporting tools (SQL queries and statistical functions) to identify

trends in errors and unexpected events. Implemented corrective and preventative actions (CAPA) as required.

Reviewed unsuitable test results and verified disposition of unsuitable products for reactive donors. Ensured

that all collection activities and manufacturing requirements were completed prior to product release.

SPHERION PROFESSIONAL SERVICES

CARDINAL HEALTH, INC. - Columbus, Ohio 10/2007 to 11/2007

Quality Test Analyst

Recruited to perform Operational Qualification (OQ) testing (on a short term project) for a global

pharmaceutical distribution company serving hospitals, physician offices and pharmacies.

Manually executed operational qualification (OQ) software testing during the firm’s conversion to an

electronic document management system. Utilized test plans in various roles to fully document each test and

any differences between actual and expected test results. Ensured that all deviations, change controls and

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corrective actions (CAPA) were documented and executed as required. Assisted in writing and editing test

scripts for performance qualification (PQ) testing.

ALKERMES CONTROLLED THERAPEUTICS - Wilmington, Ohio 8/2003 to 2/2006

Quality Assurance Systems Specialist

Supervisor Quality Assurance Documentation

Recruited to implement and review quality systems for a global pharmaceutical company developing

medicines based on sophisticated drug delivery technologies.

Lead the team responsible for converting over 3000 paper based documents for deployment to an electronic

document management system while supporting daily operations in clinical and commercial manufacturing.

Responsibilities included workflow analysis, hiring, implementation and validation testing (OQ/PQ) for

functionality and compliance with 21 CFR Part 11. Created process maps that outlined current and future work

flows. Utilized SQL queries and statistical tools to analyze performance data. Ensured that all deviations,

change controls and corrective actions found during testing were fully documented and executed as required.

Created training documentation and performed end user training for system roll out. Wrote, edited and

approved quality assurance documentation for manufacturing and laboratory functions including the annual

product review for commercial manufacturing. Drafted, edited and approved technical reports, forms,

specifications, standard operating procedures, change controls, qualification protocols and investigation

reports. Facilitated focus groups to streamline procedures and improve efficiencies. Communicated verbally

and in writing with end users, information technology and stakeholders at all levels of the organization.

Worked with regulatory affairs staff to review submissions data that included protocols for clinical studies and

data regarding the manufacture, stability and controls used to manufacture human drugs. Performed good

manufacturing and good laboratory (GMP/GLP) audits of contract laboratory and manufacturing facilities and

participated in internal regulatory audits.

NATIONAL CITY MORTGAGE - Miamisburg, Ohio 8/1997 to 6/2003

IT Business Systems Analyst

Future State Project Manager

IT Business Analyst

Performed business analysis and project management functions for large mortgage originator specializing in

originating, acquiring, marketing and servicing residential mortgage loans through retail and wholesale

channels.

Coordinated field technology and software development (SDLC) projects and initiatives in support of branches

nationwide. Acted as a liaison between information technology, subject matter experts, stakeholders,

consultants and end users. Documented business process flows that lead to the redesign of existing enterprise

technology and the implementation of new technology solutions. Prepared use case documentation and

translated technical information to end users for classroom training and software manuals. Tested system

modifications to identify and document outcomes and issues. Analyzed data and presented information that

assisted in the decision making process during the selection of new technology and the development of

complementary documentation and training materials.

EDUCATION

Bachelor of Science, Organizational Management

Wilberforce University - Wilberforce, OH

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