Chauntel J. Smith

Greater Minneapolis Area (***) 734 - 4243 aduoah@r.postjobfree.com

www.linkedin.com/in/chauntelsmith

professional summary

A healthcare information technology professional with quality assurance insight and extensive medical device experience. Who brings transformational leadership with proven training, feedback, and morale-building expertise. Results-driven personality committed to delivering high-quality products and business solutions.

skills

Sharp attention to detail, excellent interpersonal, verbal & written communication, analytical, and problem-solving skills with the ability to support multiple needs between critical deliveries. Partnership oriented – demonstrated strong relationships with teammates and internal & external customers.

METHODS: Agile, Waterfall, and Kanban

APPLICATIONS: SharePoint, AS400, Rumba, SAP, Microsoft Office Suite, Test Manager, SQL Server Management Studio, Team Foundation Server, Citrix Receiver, Point-Click Care, Postman, and Test Complete

Professional Experience

Takeda International Pharmaceuticals, Brooklyn Park, MN – Quality Assurance (QA) & QA on-the-Shop Floor Specialist III

Specialist • Leadership Team – QA Department 4/2019 - Present

Facilitated migration from Catsweb to Trackwise (QMS)

Performed UAT for Content Manager (DMS)

Participates in migration from LEADs to Veeva (DMS)

Participates in electronic design of batch records for transition from paper system to MFG Execution System (MES)

Collaborative communication with site personnel, peers, and management regarding status of QMS events

Prepares QA inspection readiness and audit response business process map

Create a business process model flowchart for logbook review & archival in the manufacturing department

Perform batch record review, logbook audits, assess safety and cleanliness on the shop floor

Updates Material Status in SAP & supports current GMP and GDP compliance

Participated in FDA & EMA licensure of Entyvio (Process C) and AdCetris

Analyzes/interprets projects & investigations to determine next steps, makes independent decision - notifies management

Supports Deviations with RCA (Failure Mode and Effects Analysis, 5 Whys, and Fishbone), CAPAs & Change Controls

Identified, proposed, and prioritized CIs for QA Process & Systems

Supports, develops and delivers training on department-specific procedures & systems (e.g., Trackwise, DE&I, and GDP)

Performs Technical Writing and controlled document review (writing new SOPs/revising existing SOPs/approving SOPs)

Participates in Global & Local DE&I Committees

AlixaRx, Eden Prairie, MN

Analyst • Software QA Team Lead & Product Management Support) – IT Dept 9/2015 - 9/2018

Collaborated with the Engineering team to support the network migration project

Tested REST APIs for customer portal in SharePoint online using Postman

Created automated Test Plans & Test Cases using TestComplete tool

Created manual Test Plans & executed Test Cases (unit, integration, functional, regression & UAT) using Test Manager

Identified/defined software defects using TFS and collaborated with developers to document & test fix

Performed DB Load Testing to validate performance, reliability and scalability

Verified pharmacy claims and payor communication in HL7 transactions using Framework Console application

Created and reviewed project-specific use cases with operations & business analysts

Supported business analysts with project-specific requests for proposals depending on related experience

Collaborated with business analysts to create process maps and gather functional requirements

Accompanied business analysts to follow up on requirements to detect ambiguities and reduce gaps in test strategy

Collaborated with QA Manager to create & deliver PPT outlining QA time estimates for projects

Supported Product Management team with creating groups, permissions, and personas in TFS

Communicated project deadlines and testing priorities to the QA team based on business needs

Collaborated with business analysts on writing & revising user stories and acceptance criteria

Completed a three-phase, nine-month project for the Emergency Medicine Cabinet (EMC) functionality

Facilitated weekly meetings with SCRUM Master to review burndown and discuss impediments

Identified, tested, and implemented time tracking tool for the SCRUM team (also trained users)

Pulled weekly report to verify SCRUM team was within budget

Provided monthly feedback to the QA team per quarterly goals to ensure time for improvement if needed

Performed hardware and software build installation in all three QA environments

Created and distributed QA release notes & provided overnight support for software upgrades

Delivered Quartley hardware training to Technical Support Staff

Created and delivered onsite QA & virtual end-user training

Created materials and delivered training for new hires in QA

Wrote and executed basic SQL queries

AlixaRx, Eden Prairie, MN

Analyst • Team Lead – Technical Support 3/2014 - 9/2015

Responsible for supporting/troubleshooting Automated Dispensing Unit (ADU), mobile (phablet), and printers

Created and delivered training for new Technical Support Analysts

Collaborated with Pharmacy and Field Service personnel to initiate refill requests and resolve order entry errors

Provided excellent customer support services for ADU to nursing staff for more than 235 clients

Answered an average of 75 calls providing first-call resolution with an average handle time of <5 minutes

Dispatched field service for onsite customer support if remote solutions failed

AlixaRx, Eden Prairie, MN

Technician • Team Lead – Pharmacy Field Service 2/2013 - 3/2014

Liaison between clients and the pharmacy team to prevent or resolve errors, issues, and grievances

Assisted Clinical Pharmacists with chart review for new admissions to stop duplicate medication therapy

and duplicate billing and tracked turn-around-times for 1st dosing

Provided remedial training to nursing staff

On-boarded all new pharmacy field service technicians

Created and coordinated training of pharmacy field service technicians

Experience with ISO Class 5 Standards (USP 797) required for training Nursing Staff to prepare emergency intravenous

as well as bulk compounds

Knowledge of FDA regulations for new medication releases, which resulted in client formulary changes

Knowledge of state and federal laws to ensure client and pharmacy compliance

AlixaRx, Eden Prairie, MN

Implementation • Team Lead – Pharmacy Specialist 5/2012 - 2/2013

Coordinated Go-Live activities, including medication waste removal for compliance and medication cart audit to prevent duplicate dispenses and billing

Delivered high-quality customer migration, staff training, and support services for >235 clients

Collaborated with Field Service Engineer to ensure the efficient onsite installation of Hardware & Software

On-boarded and trained all new implementation team members

Corinthian Colleges, Eagan, MN

Instructor • Multi-Program Instruction/Cross Trainer – Pharmacy Technician Program 2/2010 - 7/2014

Provided “real-world” experience during lab instruction for a total of four interdisciplinary programs

Lab instruction included ISO Class 5 Standards (USP 797) as well as FDA regulations for aseptic and drug

compounding techniques

Classroom instruction included state and federal law

Creatively designed, implemented, and facilitated the pharmacy insurance curriculum that led to program accreditation

Leadership Experience

Girl Scouts USA – Troop Leader 9/2015 – 9/2020

Coordinated troop meetings, events, and service projects for nine girls

Work a minimum of 200 hours each year

Eden Prairie Girls Basketball Association – Head Coach 9/2018 – 03/2019

Life Skills and Safety training, Mentor Matching for a team of 11 girls

Parent Involvement and Communication

Trained Assistant Coach

Education

The University of Phoenix, Management Phoenix, AZ

Bachelor of Science in Business Management 1/2023 2/2019

references

Nathan Krakue, Professional

Company: Takeda Pharmaceuticals

Personal cell: 860-***-****

e: aduoah@r.postjobfree.com

Charvette Gipson, Professional

Company: Takeda Pharmaceuticals

Personal cell: 832-***-****

e: aduoah@r.postjobfree.com

Dana Farris, Professional

Company: AlixaRx

Personal cell: 214-***-****

Work: 832-***-****

e: aduoah@r.postjobfree.com

Jenny Benton, Personal

Company: The CREW Urban Youth Equestrians

Personal cell: 612-***-****

Work: 651-***-****

e: aduoah@r.postjobfree.com

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