Summary
Overview
Work History
Education
Skills
Knowledge
References
Analytictools
Validationtools
Certification
Affiliations
Accomplishments
References
Timeline
Generic

COURTNEY STEPHENS

Wadsworth,IL

Summary

Seasoned IT and Quality Assurance professional with a proven track record at AbbVie, specializing in SAP QM and LotSmart enhancements for regulatory compliance and operational efficiency. Expert in cross-functional teamwork and complex problem-solving, leveraging skills in SAP SD and risk management to drive continuous improvement and strategic IT solutions. Hardworking and motivated professional with several years of experience and record of success in industry. Solid history balancing team performance, customer service targets and business objectives. Dedicated to working closely with employees to maximize productivity and optimize procedures. Decisive leader with good planning and organizational skills.

Overview

15
15
years of professional experience
1
1
Certification

Work History

Manager, QA IT Systems

AbbVie
IL
06.2021 - 11.2023
  • Act as business system owner and Global Process Lead for SAP and LotSmart and support day-to-day business functions within SAP Quality Module (QM)
  • Work closely with the SAP Quality System Integration Lead to improve SAP and LotSmart business processes and to establish the SAP Center of Excellence
  • Work with cross functional team members through the development/design process for continuous improvements of SAP QM and LotSmart functions
  • Provide review/approval for regulatory restriction updates
  • Ensure smooth roll-out of enhancements with exposure to site Qualified Persons and QA resources
  • Effectively manage and execute strategic business opportunities to improve SAP S/4 HANA and LotSmart business processes, system design, system configuration/implementation and testing
  • Setting up of QM master data across process stages, work with manufacturing sites to ensure smooth product release at finishing sites; batch genealogy, quality inspection lot, result recording, and assignment of authorized market country
  • Ensure successful master data set up for LotSmart functions to support New Product Introduction (NPI) readiness per product filings/launches targets for AbbVie products
  • Analyze business processes and elicit, analyze, and document continuous improvement requirements (CIRs) to support SAP QM functions
  • Act as liaison between SAP integration team and designated site(s) for deployment activities
  • Contribute to site enhancement request to improve operating module for QM functions
  • Ensure compliance with corporate and regulatory bodies as well as the completion of quality documentation and requirements
  • Provide consultation and training on SAP Quality Module (QM) and LotSmart functions to internal, affiliate, and cross-functional groups and integration of QM with other SAP modules, such as MM, PP, EWM, SD, and FICO
  • Lead technical professionals and global cross-functional teams during the development and evaluation of GxP requirements for qualification/validation, documentation and compliance
  • IT Project Manager: work with upper management to determine budget, resources, and timeline for integrating new AbbVie sites that will be using the LotSmart functionality to manage market authorization
  • Determine validation scope preparing project documents, including gathering of business requirements, user requirements, functional requirements, configuration / implementation for SAP QM module
  • Validation support for SAP QM /LotSmart, reviewed/approved business process documents for SAP QM modules, user requirements specification, functional requirements specification, test protocols, coordinate resources from business and SAP technical support team members
  • Developed project plan to include resources availability, allocation, risk assessment, and provide updates to key stakeholders
  • Provided guidance to business during the creation of Master inspection characteristic (MIC) for SAP QM module for result recording
  • Effectively communicate project status to key stakeholders and business users (SAP S4 Hana)
  • Delivered LotSmart integration projects on time, maintained scope, and within budget
  • Identify project deliverables based on software development life cycle methodology used for the project

Advisor / Senior Software Validation Engineer

Sysmex
IL
09.2019 - 06.2021
  • Act as an advisor to 'Company' on all business solutions and strategies for SAP S/4 HANA implementation project
  • Instrumental in areas such as functional risk assessment, Requirement gathering and documentation, and management of Change Control for computerized system validation, which includes:
  • Current validation of SAP high risk modules
  • New implementation of S4 HANA validation
  • Other products as required, such as Add-ons, Solution Manager, SAP GRC, GTS…
  • Support base business change control and quality impact
  • Manage day to day base business related to software validation support
  • Management of work assignment to QA validation engineers for maintenance/support of SAP ECC
  • Provide guidance on SDLC methodology and documentation/project deliverables
  • Assist in aligning the business with the understanding and development of the new procedures for the Product Design & Development Process (PDDP) / alignment with ASAP methodology
  • Actively participate in Data Migration effort from SAP ECC to SAP S/4 HANA
  • Provide guidance and SQA support to Non-SAP projects
  • Provide services required to benefit 'Company' in both strategy and individual customer procedures

IT Business Relationship Management - Consultant

Abbott Laboratories
IL
03.2019 - 09.2019
  • Provide guidance on systems integration and remediation projects deliverables and SLC methodology per systems criticality
  • Participate in Business/Functional Risk Assessment, requirements building and translating to functional specifications, design requirements, and project deliverables
  • Assist with the system development life cycle from Planning through Analysis, Design, Implementation, Conversion and Support to ensure compliance with regulator requirement for SAP and Non-SAP systems for Regulatory Affairs, HIPAA, Sarbanes Oxley and Quality Assurance (RA/QA)
  • Identify project deliverables and review/approve project deliverables alignment with SDLC methodology
  • Assist with Business Process Risk assessment and evaluate regulated application/systems
  • Approve/review project deliverables - Change Request, validation plan, User Requirements Specification and Functional Requirements Specification documents and other project deliverables
  • Assist with the transformation of business process requirements into the design, development, and testing
  • Instrumental in coordinate business processes and aligned IT to deliver required solution to support the business requirements

Senior Validation Engineer

CSL Behring
Kankakee, IL
06.2018 - 03.2019
  • Provide equipment and computer system validation support - HVAC and facility/utility
  • Review and approve cleaning validation protocols and reports
  • Participate in the execution of validation studies for new manufacturing equipment
  • Investigate and resolve protocol discrepancies and collaborate in the investigation of non-conformances/deviations
  • Ensure compliance with cGMP, and FDA, regulations and Guidelines and site policies and procedures, which includes the following:
  • Execute Field Studies and Performance Qualifications for Fractionation, Bulk Formulation, and Auxiliary Solutions equipment; Adsorption Modules, Filtration Skids, Transfer Lines, Equipment Washer, and Filter Presses
  • Identify critical sites and collect rinse and swab samples; perform carryover calculations; verify drainability of equipment and collecting and submitting of samples
  • Equipment Qualification: Create System specification document: HVAC, Chromatography Skid and Freezer
  • Review and provide guidance on creation of IQ and OQ protocols for HVAC, Chromatography Skid and Freezer

Validation Specialist

CSL Behring
Kankakee, IL
11.2016 - 06.2018
  • Commissioning Project: Consultant
  • The scope of work involves the execution of protocols for the Commissioning and Qualification (Installation and Operational Qualification) of Process Equipments for a new GMP facility housing production and support equipment, system alarms, input/output verification, utilities, and power failure/recovery simulations
  • Execution of commissioning protocols - component verification, P&ID verification, Vendor documentation, Material of Construction, Flow rate, Drainability, and Preventative Maintenance verification – via SAP PM module, and Temperature Mapping – distribution studies on Vessels
  • Executed Installation/Operational Qualification protocols for equipment, utilities and facilities, color metric, and riboflavin testing for Clean in Place (CIP) system in stainless steel process tanks, reactor Skids, and CIP Skids
  • Troubleshoot and elevated potential risks to the project and make recommendation during Commissioning/IOQ
  • Experience using HMI – SCADA and Werum MES application during commissioning - IOQ execution/verification
  • Experience using SAP PM to configure preventive maintenance, troubleshooting, and setting sensor and alarm (proximate sensors), and communicate within the network (control system)
  • Executed commissioning protocols/component verification, incorporate cGDP, and preparation of validation packets

Validation Engineer III

Boehringer Ingelheim
Ohio
12.2015 - 10.2016
  • Project role: IT Project Manager - SAP ECC 6.0 R/3 Integration project / Serialization project
  • Gather project requirements from various business users and technical staff members
  • Identify, question and record task dependencies, task efforts and task durations
  • Create accurate and organized work breakdown structure
  • Follow established project management guidelines and processes (e.g., System Development Life Cycle) to develop, maintain, and track project plans, conduct project meetings and report project status
  • Work with management to ensure that established policies and procedures effectively engage and utilize infrastructure resources
  • Produce or review documentation detailing the project plan, project status, individual deliverables, team member roles and responsibilities, project budget and contingencies
  • Record and report on project hours and budget spent on a periodic basis
  • Mitigate and resolve communications problems and team conflicts
  • Participate in product testing and product training
  • Provided leadership and guidance during validation efforts – product design, requirements gathering, testing, gap analysis, configuration, testing, data migration, Testing of IQ and OQ, PQ protocol execution
  • Instrumental during Functional Risk Assessment - assist in the risk analysis session to determine GAMP5 / GxP requirements impact and define the validation testing strategy based on the system complexity

Software Quality Assurance Engineer – ASI Consultant

AbbVie
IL
09.2014 - 12.2015
  • Reviewed and approved validation supporting documents, such as validation protocols, verification Checklist, user requirements, and functional requirements, etc
  • Reviewed/approved project deliverables Requirements, Design Document, Project Plan/Validation, Incident Report/Defect, and Traceability Matrix for computerized systems such as Application, eCommerce and mobile Device, and analyzed functional requirement to ensure that they are clearly defined and testable

IT Compliance Analyst

Abbott Laboratories
IL
12.2008 - 05.2014
  • Provided guidance and coordinated day to day activities for validation analysts including providing expertise in preparation/executing/compilation of validation packages as well as managing workloads
  • Reviewed functional requirement and translate to align with Users/Business Requirements
  • Performed Sarbanes-Oxley Audits (SOX) audit on the Management Information Systems platforms
  • Performed manual and electronic test execution for medium complexity projects
  • Proj Role: Software Quality Assurance Engineer – SAP Maintenance support for International sites
  • Created validation change request to clearly state the project scope, objectives and system classification
  • Assisted with defect tracking during validation testing; enhancement/new functionality, incidents/defects
  • Monitored and updated project schedule for changes and when information/milestone(s) are achieved
  • Proj Role: Software Quality Assurance Engineer – SAP/Non-SAP support (Project/Release Manager)
  • Provided Quality support for regulated/Non-regulated system during the implementation and maintenance
  • Provided guidance on SDLC methodology throughout projects implementation of ERP system (SAP/Non-SAP), Infrastructure, web application, PCI, and SaaS – remain current in software engineering best practices
  • Accomplishment: Recipient of an AIM Executive Excellence Award in recognition for providing support as Software Quality Assurance Engineer during the implementation of the SAP UPGRADE RUSSIA ERP system
  • Received a spot award for providing Validation Testing support for the implementation of SAP FI/CO module at the Columbus plant – Abbott Nutrition during the implementation of SAP ECC 6.0 ERP system

Education

PhD - Information Technology, Information Assurance and Cybersecurity

Capella University
Minneapolis, MN

Masters of Science - Computer Science, Database / Information Systems Management

DePaul University
Chicago, IL

Masters in Business Administration - Project management

Keller Graduate School Of Management
Chicago, IL

Graduate Certificate - Project Management

Keller Graduate School Of Management
Chicago, IL

Bachelor’s Degree - Electronic Engineering

Devry University
Chicago, IL

Skills

  • ISOtrain
  • ADAM
  • Plateau
  • GDRS
  • Veeva Vault
  • TrackWise
  • HP Quality Center
  • Quick Test Professional
  • DOORS
  • Agile
  • Packet Tracker Application
  • LabWare
  • LIMS
  • Telelogic Change
  • SharePoint
  • Solution Manager
  • Tableau
  • SAP BI/BW
  • SQL
  • Toads
  • Oracle
  • Microsoft Access
  • Microsoft Office Suite
  • Microsoft Project 2010
  • Visio
  • US FDA Title 21 CFR Parts
  • Cyber Security
  • COBIT
  • ITIL
  • ISO 27001
  • SAP SD
  • SAP FICO
  • SAP BIBO
  • ABAP
  • Salesforce Admin
  • Salesforce Developer
  • Policy and procedure development
  • Cross-functional teamwork
  • Complex Problem-solving
  • Project planning
  • Workforce management
  • Risk management
  • Operations management

Knowledge

Toads/Oracle, writing SQL commands, Created Microsoft Access Database for inventory tracking, Microsoft Office Suite – Access, Excel, Word, PowerPoint, Microsoft Project 2010, and Visio, 21 CFR Parts - Part 11 - Electronic Records/Electronic Signatures, Part 210/211 - cGxP in Manufacturing, Processing, Packaging or Holding of Drugs and Finished Pharmaceuticals, Part 820 - Quality Systems Regulations – validation of computerized systems/applications, Cyber Security, Information Security framework - COBIT, ITIL, ISO 27001, SAP SD & FICO, SAP BIBO, ABAP, Tableau, Completed training for Salesforce Admin and Developer in 09/23

References

Available upon request

Analytictools

  • Tableau
  • SAP BI/BW
  • Writing SQL commands

Validationtools

  • ISOtrain
  • ADAM
  • Plateau
  • GDRS
  • Veeva Vault
  • TrackWise (SolTRAQs)
  • HP Quality Center (AQC)
  • Quick Test Professional
  • Dynamic object-oriented requirements system (DOORS)
  • Agile (PLM)
  • Packet Tracker Application - Lotus Notes
  • LabWare
  • LIMS
  • Telelogic Change
  • SharePoint
  • Solution Manager

Certification

  • CompTIA Security +
  • CASP
  • CISM
  • Project Management

Affiliations

  • Present of my Home Owner Association

Accomplishments

  • Certificate for the successful implementation of SAP ERP in Russia (ABBott Site)

References

References available upon request.

Timeline

Manager, QA IT Systems

AbbVie
06.2021 - 11.2023

Advisor / Senior Software Validation Engineer

Sysmex
09.2019 - 06.2021

IT Business Relationship Management - Consultant

Abbott Laboratories
03.2019 - 09.2019

Senior Validation Engineer

CSL Behring
06.2018 - 03.2019

Validation Specialist

CSL Behring
11.2016 - 06.2018

Validation Engineer III

Boehringer Ingelheim
12.2015 - 10.2016

Software Quality Assurance Engineer – ASI Consultant

AbbVie
09.2014 - 12.2015

IT Compliance Analyst

Abbott Laboratories
12.2008 - 05.2014

PhD - Information Technology, Information Assurance and Cybersecurity

Capella University

Masters of Science - Computer Science, Database / Information Systems Management

DePaul University

Masters in Business Administration - Project management

Keller Graduate School Of Management

Graduate Certificate - Project Management

Keller Graduate School Of Management

Bachelor’s Degree - Electronic Engineering

Devry University
COURTNEY STEPHENS