Seasoned, success-driven, and multifaceted professional, offering extensive experience in software applications and management, risk assessments and mitigation, automation system development, as well as business system analysis.
Adept at overseeing large-scale and complex projects including Good X Practice (GxP) applications within various regulated environments through application lifecycle management processes. Concept-to-execution leader, capable of designing tactical plans and technology-based solutions without compromising scope, resources, and budget constraints. Expert at building and collaborating with high-performing teams toward company advancement, continuous process and performance improvement, and operational productivity. Bilingual in English and Spanish.
Areas of Expertise
Functional Testing and Risk Assessment
Change Controls, CAPA’s, NoE Quality audits
FDA/Quality Regulatory Compliance
Service Master, Memphis, Tn
Business Systems Analyst Oct 2018-Feb 2019
Requirements Management and Communication – URS-User Requirements Specification,
Software Testing – Test Plan creation and execution.
Requirements Elicitation sessions – Process workshops, AS-IS and Future process workflows utilizing Ms Visio, Use Cases
Adherence to Good Documentation Practices
Agile Methodology – Big Room Planning, (PI) Program Increment, PI objective building, and execution, Sprints, Ipswitch sprints. Releases
Jira for managing Agile
Wright Medical Memphis, TN
Business Systems Analyst Apr 2018-Oct 2018
Requirements Management and Communication – URS-User Requirements Specification, FRS- Functional Requirement Specification, RTM- Requirements Traceability Matrix, Validation Plan - Document types
Requirements Elicitation sessions – Process workshops, AS-IS and Future process workflows, Use Cases
Adherence to Good Documentation Practices
Sunset Marketing Collierville, TN
Web Developer Jun 2017-Feb 2018
Built web pages and made updates as needed
Business Analysis as needed for web trending, Sales Analytics
HCL Technologies Branchburg, NJ
Senior Technical Manager Mar 2015–Nov 2016
Managed portfolio application for Merck Manufacturing Division (MMD), Merck Consumer Care (MCC), and Merck Animal Health (AH) divisions, after being contracted back to Merck Pharmaceuticals.
Provided direct supervision to five service contractor teams.
Merck Manufacturing Division Memphis, TN
Project Manager and Senior Delivery Specialist, Application Management Oct 2009–Mar 2015
Rendered expert leadership to 24 global manufacturing application systems as well as to 15 to 20 service contractors.
Took charge of more than $3M support contracts for the managed services with $1.7M in renewals in an annual basis.
Oversaw various teams, in charge of processing and implementing more than 150 change controls.
Conducted required system risk assessments and mitigation, while quickly adapting to resource constraints, as necessary.
Drove AMS team work efforts for Windows 2007, NGCC exception process, employee engagement survey, and AppEx.
Accomplished various projects including European SQL, LIMS implementation; as well as Watson Bio implementation.
Received promotion as the principal analyst in 2012 for displaying exemplary performance in performing tasks.
Successfully integrated five Merck vendor companies into one, which resulted in $110K savings within a three-year period.
Project Methodologies Utilized: Waterfall, Modified Waterfall, Rad, JAD, Agile
PMP Certification training completed
Designed the Schering Plough software application monitors, which provided $50K in annual savings.
Played a vital role in accomplishing the following IT initiatives:
-Conversion of mainframe printing to individual report, while allocating printing to 75 printers;
-Retiring of multiple applications and systems as part of corporate initiative;
-Completion of two data center conversions, Memphis, and White House Station; and Windows 10 initiative.
Led several teams accountable for performing Enterprise System technical aspects, which included impact analysis, system change requests content and testing, disaster recovery plans, application runbooks, and system retirements.
Expertly managed and collaborated with other IT compliance teams regarding the delivery of system requirements, functional testing and risk, and requirement traceability.
Handled the managerial-level approvals for the system user access, system reboots, and downtime report notifications, as well as weekly status reports concerning problem investigation and weekly trending.
Delivered the company’s granting access for all IT system accounts.
Business Analyst experience 10 yrs.
Schering Plough, Inc. Memphis, TN
Senior Business Systems Analyst Oct 2000–Oct 2009
Held accountability in creating and facilitating client and server-side programming while planning new industry innovations and supporting general business growth.
Drove continuous process improvement by redesigning existing programs.
Made major contributions in driving planning, budgeting, and productivity, and quality management meetings.
Designed the company’s large systems, while formulating system-integration solutions, utilizing, and maintaining knowledge of multiple technologies.
Earned strong reputation for establishing a track record of technical skills building in more than three years.
Played an integral role in developing advanced program functionality and enhancing process analysis prior to program writing, thus maximized tasks automation.
21CFR regulatory experience – 17 yrs.
820 medical device experience – 10 yrs.
Earlier Career with Accomplishments
Cargill, Inc. Memphis, TN
Automation System Developer, Manager, and Analyst Jun 1989 Oct 2000
Introduced automated Cargill customer tank HMI monitors, which brought forth $50K in annual savings for the company.
Served as part of the Automation Research and Development Steering Team in implementing several online technologies, management, and process changes, thus enabling the Memphis Cargill Facility to be recognized as the #1 in profitability among five sister plans.
Led the installation of radio frequency identification readers in load-out areas to determine rail cards and their positions in the facility, which removed the need for manual data collection.
Pioneered operations of the Radio Frequency Identification Reader Project (RF_ID), which involved drafting transmittal programs, developing interfaces, and configuring optical reading devices.
Led the creation and implementation of the CIM/21 Data Historian System that was linked to the Distributive Control System (DCS), which enabled the management to better analyze the data.
Education and Credentials
Bachelor of Business Administration in Management Information Systems University of Memphis Memphis, TN
Laboratory Information Management System (LIMS) (v5.0, V6.0) System Administration; LIMS Basic Developer; LIMS Interfaces, JD Edwards, SAP, Empower, Vision Publisher, L4L, PE Waters, Vision Publisher and ELogs CLM/21 System Administration Oracle Information Technology Infrastructure Library, v2.0 SQL, DP UX, AIX 21 CFR Part 11, Part 820, Chain of custody
Pink Palace Museum; Board Member, Royalty, Ennead Cotton Carnival Krewe
Point Person, Volunteer, Multiple STARs Volunteers Benefit Partners,
(River Arts Walk, Best Buddies, Alzheimer’s’ Foundation, American Heart Association, St. Jude Children Hospital, Brooks Museum of Art, Dixon Art Gallery, Botanical Gardens)
LIMS: CRLIMS v5; Nucleus v5; GLIMS v6 (labware); NGLIMS v4.x; StabLIMS v4.x; DVPLIMS (Sql Lims); NGLDSS; STABDSS (LIMS Reporting); Cognos Reporting; LAS; Handel (Handheld Data Entry for LIMS); Webmethods; Tibco; Limslink
Computerized Maintenance Management System (CMMS): Wmmsa; Procal; Maximo v7; Data stream v7.i
Others: eSTAR (CRM); Estars; WERCs; TAB FusionRMS; Enginuity; SARA; Merck Production Scheduling System; MCC Global Demand Planning; Orchestrate (shop floor scheduling system); Bach (bottles and media culture system); MMD Quality Portal Delivery System; ALM testing tool, Provox Dcs, AB Plc., Data Historian
Sharpe, J. (1993). Patent No. Car1037. Detroit, MI: Patent Office.
Sharpe, J. (1994). Patent No. Car1683. Detroit, MI: Patent Office.