Quality Assurance Control

ANTHONY BERNARD BROWN, SR.

**** **** ****** ******

Mobile: 908-***-****

Piscataway, NJ 08854

Home: 908-***-****

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

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Summary of Qualifications:

Education:

Bachelor of Science, Data System Management - 1980

Johnson & Wales College, Providence, Rhode Island

Global Information Technology Principle Analyst able to leverage

partnerships and drive cross

team collaboration in the development and deployment of compliant

manufacturing applications;

Experienced in delivering complex, large scale global solutions

encompassing all phases of the

Validated System Development Life Cycle;

Versatile results oriented team leader who utilizes knowledge, experience

and leadership skills to

provide timely solutions, within budget and meet or exceed the needs of the

client.

Expertise:

Program design & Application maintenance Data analysis & reporting

development

GMP compliance, Global team development FDA inquiries/reporting

including 21 CFR Part 11

Data & business process Business & risk Consultant training

modeling analysis

Client focused needs End-user support Problem

analysis DB2/ Cobol programming determination/analysis/res

Manufacturing olution

application expertise

Professional Experience:

Schering-Plough Corporation

1983 - 2009

Principal Analyst

. Development lead utilizing Validated System Development Life Cycle

methodology to deliver technical solutions for manufacturing systems that

provide FDA regulatory compliance, FDA Biologics Reporting for business

critical applications such as, Advanced Manufacturing Accounting & Product

System (AMAPS), Corporate Coding Control (CCC), Quality Assurance System

(QAS) and Production Order System (POS).

. I have over twenty years of experience with CICS, COBOL, COBOL II, SQL

and, DB2. I have many opportunities to work with the business community

on many projects, including Quality and Validation groups. I worked on

many types of projects that involved working with several departments. I

have experience in leading team members, including DBA and clients.

Anthony Bernard Brown, Sr. (cont'd)

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. I have experienced supervising several people and managed projects. I am

a very good team player, always ready to response in the time of need and

work closely with management to ensure the success of the projects.

. I have received many years of train for, regulatory (including 21 CFR

Part II), SDLC and other system validation methodology

. I have many years of training others and shared knowledge with my co-

workers

. Independently support business critical Supply Chain applications -

Provide development, validation and implementation activities, ongoing

application maintenance support and end-user support.

o Corporate Coding Control (CCC) - Updates and maintains product

information which integrates with Finished Goods, Raw Materials,

Packaging Supplies, Intermediate Bulk and other business

processes. This data is vital to the company for FDA compliance.

o Quality Assurance System (QAS) - Designed, developed and

implemented an IBM mainframe version of an existing hi-profile

HP QAS system to provide business continuity for Quality Control

users, eliminating the impact of a disaster in the event the HP

system experienced a hard failure.

This system determines Quality control and Quality status of

batch information and transmits this data to several integrated

manufacturing systems. The company has a high dependency on this

application.

o Production Order System (POS) - This critical business

application forecasts planned batches for packaging and

interfaces with BOM, Central Weigh and Packaging Orders. FDA

regulated application.

. Developed and implemented all CICS DB2 programs

. Collaborated with business users for screen design and

process.

o Advanced Manufacturing Accounting & Product System (AMAPS) - ERP

system

. Developed new interfaces to facilitate Supply Chain

processes by synchronizing data between AMAPS and other

business applications.

. Participates in obtaining and understanding technology project

requirements and transforming them into supportable and business-aligned

specifications and solutions.

. Acts as a technology integrator in linking business processes and

procedures across products and platforms via interfaces.

. Monitors and tracks IT compliance with applicable audit, regulatory and

legal requirements (e.g., Sarbanes-Oxley), company policies and

procedures, and standard practices.

. Achieves direct impact on department's performance through personal

efforts and working closely with department/division, and/or functional

work groups.

. Works collaboratively with Business Partners on developing realistic,

measurable, and supportable business-aligned technical solutions.

. Develops reviews and modifies technical processes/procedures and ensures

proper change control documentation, in addition to preparing various

required documentation.

. Proactively develop relationships with Business Partners to foster

communication and partnerships to enhance IT performance and value

demonstration.

. Involved in communicating and collaborating with departments/divisions

and cross-functional teams concerning technical solution decisions.

. Suggests solutions that are innovative, practical, well-received and may

have departmental impact.

. Design, code, modify and test programs of various levels of complexity

and scope utilizing full system validation methodology

Anthony Bernard Brown, Sr. (cont'd)

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. Develop critical and timely adhoc reports for manufacturing business

areas upon request by FDA inspectors and auditors.

. Act as participant in discussions for enhancements and programming

requirements for business critical manufacturing applications and

Interfaces.

. Upon request, research and collect data across multiple systems for semi-

annual FDA Biologics Reporting requirements.

. Conduct knowledge transfer training for new consultants and perform in

supervisory capacity during their training period to oversee their

performance and progress.

. Provide in-depth application knowledge for inquiries or analysis in

support of several business critical GMP applications in collaboration

with Quality/Validation groups and the Business.

. Provide technical expertise, analytical skills and guidance to other

analysts.

. Perform complex troubleshooting for successful resolution of technical

issues.

. Provide proactive approach in anticipation of technical problems, taking

predictive measures to reduce maintenance efforts/costs drawn from

experience (i.e., implementing technical modifications or improved

processes) and knowledge of current manufacturing systems.

Additional Relevant Experience:

Technical Knowledge:

PC SOFTWARE MS Project, MS Word, MS Excel, MS PowerPoint, MS

Access, Visio

OPERATING SYSTEMS MS Windows XP and Vista, IBM Mainframe z/OS

PROGRAMMING LANGUAGES COBOL, FOCUS, SQL

TOOLS DB2, CA-Insight, IDCAMS, FileAid, Changeman, Intertest,

Jobtrac, JHS, X/PTR, Dialog Manager, CList, ABARS,

FILES VSAM, IMS/DLI, DB2, Expediter

ENVIRONMENTS CICS/MVS 4.1, TSO/ISPF

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