Juanita D. J. Email & Phone Number

Brentwood, Missouri

• Facilitates adequate completion of manufacturing investigation efforts to ensure compliance with quality and cycle time standards. Works closely, provides guidance, coaching and feedback to all groups who are involved in initiating, completing and conducting manufacturing investigations and CAPA analysis.• Gathers and analyzes historical data to identify trends and root-cause of manufacturing deviations. Recommends corrective and preventive actions to prevent/ eliminate recurrent discrepancies and leads its implementation in Operations. Measures CAPA effectiveness.• Ensures that QAR System requirements are being executed as established in the site’s SOP and corporate guidelines. Provides the necessary coaching and guidance to ensure practices are in compliance with guidelines. Is the primary contact in the resolution of conflicts and differences resulting from the resolution of Manufacturing Investigation Reports (MIRs).• Collaborates in the design and deployment of trainings to educate employees on how to report, initiate, conduct and close an investigation. Manages the QAR Certification Program and ensures its adequate implementation in Operations. Leads efforts to educate leaders and employees on OpEx methods, practices and tools.• Supports process improvement initiatives that increase quality/compliance, efficiency and safety within the Sterile Product Manufacturing facility

United States

Performed as the GCS Subject Matter Expert (SME) for the new MasterCard Track B2B Software Application for the Software Engineering Operations & Technology department .The application launched September 2018.Actively attended weekly National Trade Platform Executive, Project Support Readiness, and Customer Delivery Team meetings to discuss the B2B Application Customer On-boarding Process, status tracking, and project deadlines with the project team members and business owners in the Singapore, UK and US regions.Delivered the company’s Global MasterCard Track Application Awareness Training and the Track Application Deep Dive Technical Global Commercial Support (GCS) training to over 200+ Support Specialists, business leads, and managers located in the US, UK, and AP region.Worked alongside the Service Design and Integration manager to ensure a successful product delivery roll-out was launched to all the Global Commercial Support teams that would support the new MasterCard Track Application.Worked closely with the third party vendor in merging current business processes and developing new support escalation processes.Worked with the Application Test Team providing application smoke testing for the B2B software application in the Test, UAT, and Production environments, while logging product defects while meeting critical deadlines.Authored the GCS Support Confluence/Knowledge Base contents and associated Global Customer Support documentation including new product information, application support scenarios, Support one-pagers, MasterCard Track customer process flows, MasterCard Track PowerPoint presentations, technical training documentation, for the Global Customer Support team, new product users, and external teams.

O'Fallon, Missouri, United States

• Delivered the company’s Global MasterCard Track Application Awareness Training and the Track Application Deep Dive Technical Global Commercial Support (GCS) trainings to over 200+ Support Specialists, business leads, and managers located in the US, UK, and AP region. Worked with the Application Test Team providing application smoke testing for the B2B software application in the Test, UAT, and Production environments, while logging software bugs/defects while meeting critical deadlines.• Authored the GCS Support Confluence/Knowledge Base contents and associated Global Customer Support documentation including new product information, application support scenarios, Support one-pagers, MasterCard Track customer process flows, MasterCard Track PowerPoint presentations, technical training documentation, for the Global Customer Support team, new product users, and external teams.• Trained a Support counterpart in the Asia Pacific region on the Track Application and Track testing techniques.• Supported the Global Commercial Support (GCS) team with additional internal projects including observing and reviewing release strategies within (GCS). Provided valuable insight and guidance by authoring the Global Commercial Support (GCS) Application Release Playbook.• Provided technical support to the MasterCard Track customers via the GCS ticketing system and phone support.

Maryland Heights, Missouri

Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and facilities/utilities supporting these operations. Validations executed included of computerized systems, software, analytical instruments, utilities, and manufacturing equipment. Executed 60 protocols a year from authoring to final summary completion. Projects included working within the R&D, AR&D, QA, Metrology, Outside Suppliers, and Engineering departments.Analyze technical equipment data, including Cleaning equipment, tablet press, autoclaves, glass washers, blend totes, process tanks; utilizing statistical methods, generated by validation studies performed by the validation group to determine process capabilities.Investigate and resolve deviations/exceptions from the predefined acceptance criteria.Draw conclusions from equipment and cleaning verification data, observations, deviation/exception and investigation as to whether process is considered valid.Write summary reports for validation/qualification protocols following criteria as outlined within the validation/qualification procedures and policies.Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.Checks project status and upload final reports into the Track wise Change Control Management system.Ensure protocols, verifications, validation plans and summary reports generated during validation/ qualification activities are stored according to procedure.Gather current knowledge from QA/QC, regulatory, periodicals and/or appropriate training programs.Interact and coordinate compliance efforts with other departments including Operations, Engineering, QA, laboratories (QC and R&D) and R&D to provide a high degree of assurance that all qualification/validation activities, where appropriate, are completed.

Creve Coeur, Mo

Responsible for engaging customers in the roll out of enterprise-level software systems developed by the TPS IT team for our multi-functional, multi-crop Technology organization. The Software Application Specialist will assist with software deployment, training, user adoption, software documentation, and act as a scientific liaison between our customers and our internal team to define a short term development strategy for software implementation.Worked as a Project Coordinator for all software testing activities while working in an Agile Methodology environment. Coordinated software smoke testing activities during the R&D Software Sprint Release and Database Failovers Event. Coordinated the Test Plan strategies, testing scripts, and communications with the St. Louis, Missouri (STL) and the Bangalore India (BLR) Support teams.Authored Outage and Release Communications pre and post for software release’s detailing all new features and software updates.Responsible for preparing application release documentation, testing scripts, managing the test tracker tool prior to software releases. Actively communicated with the IT Developers, Project Scrum team, Release Managers, IT Support team, Managers during pre and post activities throughout the application deployment Sprint process. Provided customer support within the Global Support IT department through online support, power point presentations and updating the Knowledge Base team site to ensure the customer is familiar and understands the applications new features and workflow. Responsible for logging and resolving user support issues within the Remedy Issue tracking System, escalating complex customer issues to the appropriate problem management and software developers. Applications supported include Business Objects and Vegetable software applications.

Creve Coeur, Missouri, United States

Performed User Acceptance Testing (UAT) for customer during IT builds. Developed UAT questions and designed survey questionnaire using SurveyMonkey for end of testing customer feedback and overall user experience. Relayed customer experience information to the IT developers for possible user design, ease of workflow, and user interface enhancements. • Trained and launched new Enterprise-level software trainings to Field Researchers, Compliance Leaders, and business stakeholders at a multi-functional, multi-crop IT Company.• Provided user training and prepared supporting documentation to drive user adoption and ensure proper, maximized use of platforms.

St. Louis, Missouri

Authored and Executed Liquids Validation Protocols for New Liquids and Powders Initiative projects. Authored validation test plans, Experimental Orders (EO’s), and validation summary reports.Communicating with start-up team and coordinating activities concerning validation plans, start dates, timelines, and schedules surrounding the validation activities in the Liquids and Powders Making and Packaging at the St. Louis Plant Manufacturing Site.Interacting with the Product and Development departments to ensure validation efforts were successfully executed. Prepared necessary document Change Control Documents and Experimental Orders for new projects. Consistently met timelines leading up to a consumer product launches.Worked on the packing floor production lines during validation execution.Gathered materials, worked in the RTCIS system to prepare “Hold/Release” product during validation.Worked closely with QA in coordinating validation and regular product releases.Responsible for participating in Investigations and Root Cause Analysis surrounding product Out of Specification (OOS) Results.Reported all activities results and updates to the New Initiatives Launch Manager and individual Brand Start-Up Teams.

Chesterfield, Missouri

Responsible for resolving customer complaints and inquiries. Responsible for the selection of equipment vendors and approval of equipment vendor services.Managed outside equipment vendors by planning and scheduling maintenance activities of analytical laboratory equipment. Reviewed contract and OEM preventative maintenance and repair documentation for adherence to GMP compliance. Prepared the Out Of Tolerance (OOT) and Out Of Service (OOS) notifications for non-compliant test results.Responsible for managing Analytical Lab Equipment system database of over 5,000 units. Selected to participate in a Go LIVE - Global Operations project to implement a more efficient Customer Service base. Responsible for sharing ideas that led to a more efficient unit of quality systems across Pfizer Inc. research operations.Received several inside customer service awards from Research Colleagues for demonstrating customer focus and managing change effectively in spring of 2007.In 2006 designed the Customer Services Technical department processes, and conducted training which eventually led to a major Research Services department within Global Operations for Pfizer Inc. Responsible for reducing customer complaints by 20% within 6 months.

Hazelwood, Mo

Responsible for writing and editing System Validation Protocols for a new Medical Device in the (QSV) Quality Systems Validation Department. Executing test cases to demonstrate functionality of the instrument hardware, firmware, and software for Microbiological/ Clinical purposes. Executing functionality testing, regression testing, and acceptance testing.Ensuring equipment specifications and system requirements were being met through test cases.Reported and documented defects to the IT Business Analysts, System Engineering, and Quality Departments during validation activities. Obtained 21CFR11 compliance experience. Participated in “Dry-Run” validation activities prior to formal validation start-up.Generated deviation logs into an Excel spreadsheet. Prepared Validation Summary reports.Instrumental in the September 2004 launch of the VITEK Compact API Medical Device.Participated in an ID Equivalency Study for the Clinical Affairs Group. Performed on subsequent validation projects including regression testing, testing updated software applications, taxonomy changes, and various change requests.

Greater St. Louis Area

Senior tester for incoming regional blood products for the presence of HIV, Hepatitis C, and the West Nile VirusTested in a fast paced, clean room environment while performing cGMP during the assay.Performed and documented maintenance duties and troubleshooting of automated equipment including the TECAN. Review regulated documents, batch records, and work procedures.

Greater St. Louis Area

Performed customer consultations to understand customer color needs for food products. Gathered requests and logged issues to ensure commercial customers color request were made according to user requirements and specifications. Ensured color samples were delivered on time. Once samples were approved, batches were produced in bulk, tested, and shipped to customers (Kraft, Hershey, Kellogg’s, etc.)Played an essential role in preparing sample batches of product in a laboratory setting and performed chemical testing on various color Liquid Colors, Lake Blends, and Color Dispersions for commercial customers. Tested in-process and finished color products for color, shade and strength in an Analytical laboratory using various techniques and work instruction. Instrumentation used included spectrophotometers, viscosity meters, moisture balances, analytical balances, and colorimeters. Communicated routinely with the production department, Customer Service Laboratory (CSL), and direct management.