Medical Device Training Coordinator

Stefanie Lafond Atlanta, GA 678-***-**** ****************@*****.***

4+ years’ Labeling Management and Documentation Specialist compliance in the medical device industry.

•Successfully identifying Design Changes, Instructions for Use (IFU), managing current product lines, package labels, translations, and other relevant labeling components/processes, and increasing efficiency by 45% through process improvements.

Work Experience

Quality Systems Document Specialist

SpectraForce / Boehringer Ingelheim - Gainesville, GA May 2024 - 5 month contract

●Document Management (controlled and batch packet documents)

●Logbook Management-Prepared, created and issued

●Received completed documentation records and logged into the electronic tracking system.

●Records archiving

Documentation Labeling Specialist – EU MDR

BARD / Becton Dickinson (BD) – Covington, GA, March 2021 – March 2024

SME working with cross-functional teams to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 (US) Medical Device Labeling, ISO 15223 Medical Device Symbols, and EU MDR.

•Manage CAPAs and follow-up to monitor effective resolutions.

•Initiate Design Changes for new and revised labeling, work with the Labeling team to create, maintain, and implement compliant labeling, support current product lines, review product labeling against indicated content, and approve / release labeling.

•Facilitate redlining and the development of content for labeling; manage the labeling process for approvals and ensure implementation of labeling at manufacturing site.

•Demonstrates leadership and communication skills, as well as a broad understanding of label and IFU development, Design Change Management systems, procedures / concepts, and labeling, Barcode, and Thermal Transfer systems.

•Completes a multitude of audits to ensure accurate implementation of observations and changes per approved departments.

Data Migration Specialist

Kelly Services / Halyard - Owens & Minor – Alpharetta, GA, Contract, June 2018 – September 2020

Analyzed and evaluated internal cGMP controls, policies, and procedures; proposed recommendations and provided support for operational improvements. Managed Gap Analysis in order to track monthly Key Performance Initiatives (KPIs) to ensure project objectives, scope, and deliverables meet expectations and that projects are delivered on-time, on-budget, and meet stakeholder specifications.

•SME with multiple manufacturing businesses and property management groups managing Data Migration process to ensure quality assurance requirements are in place, controlled, and met cGMP and other regulatory requirements.

•Managed the operation of billing functions such as AP / AR and Requisitions in SAP for purchasing of raw materials.

•Coordinated with the client to determine data needs, including the types of data to be migrated and how to monitor progress on the project to ensure that it is completed timely and within budget.

Account Management – Supply Chain

Allnex – Alpharetta, GA, Contract, April 2018 – May 2018

Negotiated commitment dates and enforcement for Order Fulfillment (pricing, product availability, product specification sheets, shipment tracking, etc.). Collaborated with cross-functional business units to ensure documents were generated correctly and sent to customers. Managed routing and fulfillment of customer requests.

•Managed Gap Analysis in order to track monthly Key Performance Initiatives (KPIs) to ensure project objectives, scope, and deliverables meet expectations and projects are timely, on-budget, and meet specifications.

•Accurately managed Sales Orders, Purchase Orders, and Consignment Billings entry process as it relates to account number, price, terms of sale, product, ship to/sold to, and quantity; achieve an ODR (Order Defect Rate) of less than 30%.

•Efficiently enter Orders from multiple sources (EDI, PDF, Portals) by following the standardized processes implemented from a technology and execution standpoint to drive productivity. Enter Orders timely to achieve an Order Cycle Time (OTC) of 48 hours.

French Canadian Export Sales Coordinator

EXIDE Technologies – Alpharetta, GA, Contract, September 2017 – January 2018

Actively reviewed Open Orders daily to proactively resolve Orders pending Hold release or confirmation. Adhered to documentation policies by verifying and storing Sales Orders, POs, and Consignment counts into the appropriate folders for Global and International entities.

•Maintained system accuracy on all sales and back orders to track shipment dates and changes and enter appropriate reason code entering billing transactions.

•Collaborated with Sales Representatives regarding price inquiries, discrepancies on customers Purchase Orders, and Order Status.

•SME on various Systems including JDE, SFDC, in Contact, CPQ.

Sales Support / Order Entry

KAVO KERR Co. – Alpharetta, GA, Contract, June 2016 – January 2017

Actively reviewed Open Orders daily to proactively resolve Orders pending Hold release or confirmation. Adhered to documentation policies by verifying and storing Sales Orders, POs, and Consignment counts into the appropriate folders for Global and International entities

•Maintained system accuracy on all sales and back orders to track shipment dates and resolve disputed items according to established policies and procedures.

•Collaborated with Sales Representatives regarding price inquiries, discrepancies on customers Purchase Orders, and Order Status.

•Consecutively maintained #1 spot in closing customer database orders successfully daily.

Health Safety & Environmental Coordinator

ACE USA / CHUBB, Alpharetta, GA, January 2004 – August 2015

Created and enforced a culture of safety within our organization. Ensure adherence to all relevant legal rules and regulations. Educate and oversee employees on health and safety procedures and regulations. Keeping abreast of industry and market trends and best practices.

•Encouraged and promoted the use of safer work equipment, materials and supplies.

•Reported to Occupational Health and Safety Administration (OSHA) and other relevant organizations to record assessment results and generate reports.

•Collaborate and build long-term relationships with key stakeholders such as legislators and politicians.

Skills

Regulatory Compliance & Standards

•cGMP / GxP / GCP / GLP / GDP

•21 CFR Part 11 / 210 / 211 / 801 / 820

•FDA regulations

•ISO Standards 13485 / 15223

Training & Auditing

•Internal Auditing

•Training & Development

Quality Management & Documentation

•Document management / OnBase / SharePoint

•QMS / LMS / eDMS / eTMF / SQL

•Writing / Managing SOPs

•Complaint Handling

•Corrective & Preventive Actions

•Deviations

•Root Cause Analysis

Project Management & Process Improvement

•Design Changes

•Multifaceted Project Management

•Process Improvement

•Databases

•Lean Manufacturing & Controls

Languages

●Bilingual – French (Fluent)

Education

University of Florida (Liberal Arts) - Non degreed credits obtained

SNHU South - anticipated graduation: 2025

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