Quality Assurance Control
Resume:
ANTHONY BERNARD BROWN, SR.
Piscataway, NJ 08854
Mobile: 908-***-****
*************@********.***
SUMMARY OF QUALIFICATIONS:
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 & development
* Application maintenance
* Data analysis & reporting
* GMP compliance, including 21 CFR Part 11
* Global team development
* FDA inquiries/reporting
* Data & business process modeling
* Business & risk analysis
* Consultant training
* Client focused needs analysis
* Manufacturing application expertise
* End-user support
* DB2/ Cobol programming
* Problem determination/analysis/resolution
PROFESSIONAL EXPERIENCE:
1983 to SCHERING-PLOUGH CORPORATION
2009 COBOL CICS/DB2 Developer
* 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 had 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.
* I have experience supervising several people and managing projects. I am a very good team player, always ready to respond in the time of need and work closely with management to ensure the success of the projects.
* I have received many years of training for regulatory (including 21 CFR Part II), SDLC and other system validation methodology
* I have many years of training others and sharing 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.
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.
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.
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.
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
* 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:
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 V7.1, CA-Insight, IDCAMS, FileAid, Changeman, Intertest, Jobtrac, JHS, X/PTR, Dialog Manager, CList, ABARS, Expediter
FILES: VSAM, IMS/DLI, DB2
ENVIRONMENTS: CICS/MVS 4.1, TSO/ISPF
EDUCATION:
Bachelor of Science, Data System Management
Johnson & Wales College, Providence, Rhode Island
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