Summary
Overview
Work History
Education
Skills
Languages
Affiliations
Timeline
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William A. Serrano

Tampa,FL

Summary

Highly experienced and well-organized QA and CSV/CSA Analyst with ten years of combined experience in GxP documentation, project management, process documentation, business analysis, software testing and data management. Experienced Validation Lead in documenting and ensuring GxP computerized systems does exactly what the systems were designed to do in a consistent and reproducible way, ensuring the integrity and security of data processing, product quality, and complying with GxP applicable regulations. Exceptionally well-versed in working closely with Business and development teams and effective execution and organization across multiple projects and tasks.

Overview

14
14
years of professional experience

Work History

Manager, GPS and Cell Therapy-IT Validation Serv.

Bristol Myers Squibb
06.2019 - Current
  • Provide planning, support and execution of CSV activities for RND, GMS, Research and Corporate applications simultaneously and efficiently.
  • Actively involved in reviews of key CSV lifecycle deliverables such as Solution Implementation Plan (SIP), Solution Implementation Summary (SIS), Validation Plan (VP), Data Migration Plans and Summary Report, Validation Summary Report (VSR), Test Plan, Test Summary Report and Release for Use Memo.
  • Work with Business and Development teams to update living documents such as Regulatory Risk Assessment (RRA), Requirement Specification Document and Design Specifications Document.
  • Advise and discuss opportunities for simplification with Business and Development teams that yielded to faster turnarounds and better quality and clarity of system releases.
  • Assisted in Commercial Service Now application in implementing multiple global releases such as Madrid release R9.0, Madrid, R.9.2.3 Release and Release R9.2.7 CMBD Expansion.
  • Work closely with RND breed of applications such as Pharmaceutical Development Laboratory Information Management System (PD LIMS),
    Watson LIMS, PRISYM CLIP, PK PD Analysis and Modeling System (PAMS), Pharmacokinetic Modeling and Simulation (PKMS) and GMS application Sample Management LIMS.
  • Facilitate Computerized System Validation strategies to identify governing regulations and validation deliverables during development of new and existing changes to computer systems.
  • Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues.
  • Assist in planning, reviewing, implementing, and documenting User Acceptance Testing and System Testing.
  • Participate in establishing standard quality and validation practices.
  • Follow IT Quality Management SOPs to assure adherence and compliance.

Digital Assurance And Integration QA Tester

Johnson & Johnson
08.2018 - 05.2019
  • Perform User Acceptance Testing for compensation systems and integrations for the crediting aspect of the application.
  • Develop test strategies and test cases in an Agile environment.
  • Record test cases, test results and defects in Jira.
  • Looked beyond testing scripts to check software for interconnected problems not covered by established specifications.
  • Collaborated with clients from concept through final delivery of product or service.
  • Coordinated with systems partners to finalize designs and confirm requirements.
  • Consistently met deadlines and requirements for all implementations in current sprint.

Field Force Management UAT/QA Tester

Bristol Myers Squibb
10.2014 - 05.2018
  • Performed User Acceptance Testing for the various field operation sale-force applications. 
  • Contributed to the Business process from documenting business needs to successful implementation.
  • Executed and documented User Acceptance Testing and certification activities that contribute to ensuring field platforms and related solutions are in compliance with state and federal regulations and company policies.
  • Performed end-to-end and integration testing. 
  • Contributed to the computer system validation documentation maintenance  for the Field Platforms and Pre Go Live/ Transitional Implementations.
  • Tested and supported Salesforce and Veeva tool solutions for the Field Force.
  • Conducted validation activities for new development and changes in regulated systems and business processes in an Agile environment.
  • Participated directly with business and IT stakeholders to discuss and confirm new system solutions and finalize requirements.
  • Discussed with IT and Business teams the impacts of different implementation alternatives.
  • Proficient in Workday application and its various components such as compensation tracking, time off request and tracking, performance tracking and career profile and job search. 
  • Assisted in the design, development and implementation of test plans, strategic guides and scripts using detailed business requirements documents provided by the businesses.
  • Recorded and documented all testing efforts and defects found during testing in HPALM software.
  • Ensured all functional requirements and specifications were met within the systems in the stipulated time frame.

Client Risk Framework Specialist / Validation Tester

Citigroup
02.2014 - 10.2014
  • Completed and revised the Enhance Due Diligence documentation profile for all clients enrolled in the Citigold program.
  • Assisted Financial Advisers and Relationship Managers by coordinating the collection and documentation of KYC (Know Your Customer) information reviews in the OneSource system.
  • Documented all calls and interactions with Relationship Managers on Salesforce.
  • Verified investment and brokerage account gains and client's financial profile using NetX 360 and Eclipse software.
  • Discussed ticket status on weekly calls with management and build reports documenting progress.
  • Performed calculations on client source of wealth and principal savings to determine client eligibility.
  • Assisted in the elaboration of risk assessments, validation plans, test plans and test scripts for routine UAT testing.
  • Ensured all assigned profiles were revised and completed by the end of the day.

AML Implementation and Production Support UAT Tester

Citigroup
04.2013 - 02.2014
  • Performed User Acceptance Testing to the Anti Money Laundering software for various regions globally.
  • Coordinated with systems partners to finalize project scopes and confirm requirements.
  • Provided UAT testing status information to the QA lead, project manager, and various business stakeholders.
  • Developed and executed test cases using automated tools such as HP Quality Center.
  • Executed test cases, performed functional and regression testing and ensured the execution of UAT test cases and documentation of test results.
  • Led an off-shore testing team of eight people.
  • Translated testing documentation and procedures from English to Spanish for various on-shore and off-shore teams.
  • Served as liaison between IT, compliance and end users in project discussions.
  • Assisted in the design, development and implementation of test plans and test cases using the detailed business requirements documents provided by the businesses.
  • Followed standard AML investigation process as defined by Operations Procedures to ensure the testing of systems functionality was being performed correctly.

Data Entry/Quality Control / UAT Tester

DDS Lab. Dental Solutions
11.2010 - 05.2013
  • Accurately performed data entry of scripts and clinical of removable prosthetic, partials, complete dentures and complete line of products of crown and bridge, implants and orthodontics.
  • Supervised a group of five people in the absence of the supervisor while maintaining daily production and goals.
  • Discussed dental cases with Dental Technicians to assure the correct product is entered in the system.
  • Performed User Acceptance Testing of dental software in various system enhancement projects.
  • Participated in daily meetings with the Technology team to report issues found.
  • Assisted in the building of test plans and strategies to improve testing timelines.
  • Developed and executed test cases using automated and manual tools such as HP Quality Center (HPALM).

Education

Bachelor of Science - Industrial Microbiology

University of Puerto Rico
Mayagüez, Puerto Rico

Skills

  • CSA/GxP Documentation
  • Agile Methodologies
  • Strategic Thinking
  • Excellent written and verbal skills
  • Project management
  • Quality Assurance Testing
  • Process documentation
  • End-to-End Testing

Languages

  • Fluent in English and Spanish

Affiliations

  • Member, Toastmasters International (2014 - Present) - Competent Communicator (CC) and Advanced Leadership Bronze (ALB) designations achieved.
  • Core Team Lead, Organization For Latino Achievement (OLA).

Timeline

Manager, GPS and Cell Therapy-IT Validation Serv.

Bristol Myers Squibb
06.2019 - Current

Digital Assurance And Integration QA Tester

Johnson & Johnson
08.2018 - 05.2019

Field Force Management UAT/QA Tester

Bristol Myers Squibb
10.2014 - 05.2018

Client Risk Framework Specialist / Validation Tester

Citigroup
02.2014 - 10.2014

AML Implementation and Production Support UAT Tester

Citigroup
04.2013 - 02.2014

Data Entry/Quality Control / UAT Tester

DDS Lab. Dental Solutions
11.2010 - 05.2013

Bachelor of Science - Industrial Microbiology

University of Puerto Rico

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William A. Serrano