Diane Smith
Wonder Lake
Summary
Dynamic QMS Administrator with extensive experience in Biomedical and Pharma, excelling in document management and customer service. Proven track record in implementing system features and training staff, enhancing operational efficiency. Adept at leading cross-functional teams and providing exceptional support during audits, ensuring compliance and quality standards are met.
Overview
9
9
years of professional experience
Work History
QMS Administrator
Sterling Pharma Solutions
01.2023 - 04.2024
- Supported staff as in-house admin of Mastercontrol QMS software.
- Responsible for the creation and implementation of new system features and reports.
- Assisted in the onboarding of newly acquired facilities into QMS software including creation of site specific eForms, organization of facility documents, and training records.
- Lead system clean up efforts across system modules.
- Maintained personnel records and updated internal databases to support document management.
- Provided exceptional customer service to both internal and external stakeholders through prompt response times and thorough issue resolution efforts.
- Served as on-site system expert during MasterControl implementation in Cary, NC and Ringaskiddy, IRE providing on the spot troubleshooting, employee support, and remediation of system documents and workflows as required.
- Provided on demand audit support.
- Managed employee IT tickets for Germantown, WI and Cary, NC facilities and served as backup for overseas locations.
DOCUMENT CONTROL AND TRAINING COORDINATOR
Tecomet
07.2022 - 01.2023
- Responsible for maintenance of Document Control and Quality training functions, including the creation and update of controlled documents.
- Supported staff as in-house admin of ETQ QMS software.
- Collaborated with department leads and managers to design customized training plans aligned with organizational goals.
- Coordinated logistics for training events, including scheduling facilities, securing necessary equipment, and managing participant registration.
- Assisted with customer and regulatory body audits including document preparation and retrieval.
- Oversaw archival process for facility documentation.
Consultant
ProPharma
11.2021 - 07.2022
- Responsible for remediation of Document Control and Quality training functions including update to employee training requirements and updates to controlled documents to include instructions to new ERP and QMS systems.
- Supported staff throughout the facility as in-house admin of ETQ QMS software.
- Collaborated with cross-functional teams to successfully deliver comprehensive solutions for client (Tecomet).
Document Control Lead and Training Coordinator
Gauthier Biomedical
02.2016 - 11.2021
- Distribution of workload for the Document Control Department, including supervision of department employees.
- Supported staff throughout the facility as in-house admin of QT9 QMS Software.
- Managed and led onboard ISO training in addition to maintaining training for existing staff. Including introductions to ISO 13485, 21 CFR Part 820, and applicable internal SOP.
- Maintained Document Control System including controlled document assignment, creation, revision, training, implementation, and distribution of all new or revised company procedures.
- Developed and maintained document templates to streamline employee documentation updates and provided formatting and proofreading checks to all controlled documents.
- Maintained Document Change History documentation.
- Managed and maintained customer and supplier documentation systems including management of agreements, customer SOP, and supplier certifications.
- Provided on demand audit assistance, retrieving original records, making reference copies to procedures, and answering to Customer and Regulatory Auditors as required.
- Collaborated across departments and levels of management to gain consensus on procedural documentation.
Document Control Specialist
Gauthier Biomedical
02.2015 - 02.2016
- Responsible for review of production documentation, ensuring accuracy and appropriate completion of documents in addition to assembly and distribution of production documentation.
Education
Bachelor of Arts - English
Ripon College
Ripon, WI12-2014
Skills
- Customer service
- Document management
- MS office
- Data entry
- Attention to detail
- Recordkeeping and file management
- Administrative support
- Employee supervision
Timeline
QMS Administrator
Sterling Pharma Solutions
01.2023 - 04.2024
DOCUMENT CONTROL AND TRAINING COORDINATOR
Tecomet
07.2022 - 01.2023
Consultant
ProPharma
11.2021 - 07.2022
Document Control Lead and Training Coordinator
Gauthier Biomedical
02.2016 - 11.2021
Document Control Specialist
Gauthier Biomedical
02.2015 - 02.2016
Bachelor of Arts - English
Ripon College
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