OBJECTIVE:

I am seeking a challenging and opportunity position in Quality System Operation or Production Manufacturing Process. My background is in pharmaceutical and medical devices industry.

EMPLOYMENT HISTORY:

Confidential, 2002 to 2012.
(Site in Closing Transition) 
Position: Business Technology (Quality System – Administrator)

• Support Information to Management and Users in the organization on how to use various types of software efficiently and effectively in fulfilling business objectives. This includes Labware LIMS, Empower CDAS, Trackwise, GxPharma, Isotrain , MES, OpenLab,
• SAP QM and Minitab. Primary responsibilities include Project and Change Management, Validation Requirements, Revision, Bugs,
• Upgrades, New Release, Decommission, Improvement, Maintenance and Enhancement the Compliance Quality System Operations.
• Software Implementation: Establishes the Business Rules and Validation Requirements for Software Quality Application. In this
• Application evaluates strategy of Business Requirements and Technical Designs. Coordinate the activities of team members to create the following documents in order to define validation requirements as: Workflow As Is, Workflow To Be, Functional Requirements,
• Change Control, Project Plan, Validation Plan, Training Plan, SOP Plan, Impact Assessment, Traceability Matrix, Master Data Load,Validation Summary, IQ-OQ-PQ Summary, Disaster Recovery Plan, Backups, User Guide, Work Instructions, Training Job Aids and Test Script Executions.
• Labware LIMS Deployment: Experiences in coordination and deployment for Master Data Team Build Objects, Standard & Reagents, Instruments, Labstation, Chemical and Microbiology Analysis, Product Specification, Environmental Water, Air & Surface, Master and Explore Table, Menu and Toolbars, Security Users and Roles, Lot Manager, Labels, Reports, Charting, Project Validation Samples and data migration from Development to Quality and then to Production environments.
• Labware LIMS Configuration : Provide Functional Requirements of Table Master and Build Objects configuration for Standard & Reagents, Labels, Reports, Analysis and Product Specification that were applicable to following link build objects: Access Routine, Query Tag, Store Query, Analysis Rules, Test List, List, Subroutine, Process Stage, Process Equipment, Location, EM Tables, Common Name, Folder Template, Lot Template, Project Template, Protocol Template, Parsing Script, Approval Role, Approval Routing, Time Point, User, Worklist Link, Worklist Protocol, Worklist Template, Worksheet Template, QC Sample, Inventory Location, Format Calculation, Analysis Type, Ad Hoc Component, Condition, Investigation Template, Units, Events, ID_ Configuration, Product, Analysis, Instrument Template, Electronic Laboratory Notebook and other tables.
• Development of computer software validation efforts CFR 21, part 11 and test codes, writes and /or executes software test scripts
• Work includes initial functional requirements gathering, system requirement specification (SRS), system design specification (SDS), software development life cycle (SDLC), Development and Deployment to support Labware LIMS Laboratory Operations.
• Assist in the training of users, writing and perform training modules along with technical support for user and managers questions.
• Provide the support to Global Core Team: Information Technology, Manufacturing Process and QA/QC System Operations.
• Subject Matter Expertand provide support to External Site Operation as NJ, NY, PA, Guayama-PR, Carolina-PR
• Experience Labware LIMS configuration for applicable Product Specification: RM, Intermediate, Finish, Stability, Retain, Cleaning, Labware Instrument Configuration is applicable to HPLC, GC, Dissolution, IR, KF, AA, Balance, Printers, Oven, Column and others.
• Crystal Report configuration: Analysis and Product History, Sample Label, COA, Test Results, Instrument Calibration, S&R, Stability.
• LIMS Interface configuration: Experiences with Empower CDAS, Balance, Caliper, PH Meter, SAP QM, Trackwise, OpenLab.

Confidential. 1998 to 2002. 
Position: Laboratory Supervisor 
Supervise the chemical and microbiological laboratory testing for two-shift operation. Assure the proper use of the laboratory resources to support technical functions in the validation /qualification process in manufacturing operations. Coordinate activities of Product 
Disposition, OOS and Investigation report. Evaluated Trend Analysis, Metrics, Corrective Actions and Compliance Audit Inspection. Also assisted implementation and support validation of SAP QM Module in Puerto Rico and Santo Domingo operations.

Confidential. 1994 to 1998.
Position: Senior Chemical Analyst
Responsible to coordinate chemical laboratory testing for raw material, stability and finished products in second shift operation. Experiences with reviewed and approved analytical test report. Assure laboratory personnel follow proper testing standard procedure, GMP’S, GLP’S and Safety precaution. Perform and evaluated laboratory investigation report and assure corrective action to prevent recurrences. Experiences with IQ, OQ, PQ, Protocol, Cleaning Validation, Calibration, Documentation, SOP, Regulatory audit by Safety, DEA, FDA. Also experiences with the following chemical analysis: GC, HPLC, UV/VIS, IR, Dissolution, Karl Fischer, TLC, PH meter, Microscopy particle examination and others.

Confidential. 1990 to 1994.
Position: Process and Packaging Supervisor
Responsible to coordinate Aseptic formulation, Sanitization, Change Over, Weighing, Cleaning, Glassware and Filling operations. Handling WFI, Tanks, Nauta, Koruma, Kettles, Pumps, Mixers, Blenders, Mills, Transfer Line, Chiller, Tubing, Oven and Filtration. Experiences with Lyophilization, Adhesives, Paste, Cream, Shampoo and Supervision employee’s activities to assure the proper use of these resources. Performed Manufacturing Investigation report, Packaging reconciliation, SOP revisions, Protocol, GMP’S and Safety training, Personnel evaluation, Special Project Management, Regulatory documents and inspections.

Education:
Graduate Bachelor’s Degree in Science - Major Chemistry,