Maggie Wynn

Dynamic and results-driven professional with extensive experience managing a team of ten and overseeing the development, configuration, and maintenance of MES software. Proven track record of success in implementing MES POMSnet across eleven manufacturing production labs, while effectively managing day-to-day operations, including production support, change control, and user training. Adept at fostering team development, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements to drive process improvements and facilitate professional growth and development.

• MES Technical Specialist, 12/2018, 11/2019, System Administration and Decision-Making: Orchestrated system configuration and made critical business decisions pertaining to system management, ensuring alignment with organizational objectives., Technical Support and Issue Resolution: Provided expert technical guidance and support to end-users, effectively troubleshooting and resolving complex IT challenges to uphold operational efficiency., Change Control Procedure Management: Designed, implemented, and maintained a robust change control procedure for MES changes, including custom design of MasterControl process forms and collaboration with QA and Manufacturing Management to optimize processes., Tailored End-User Training: Developed and delivered tailored end-user training programs for various manufacturing labs, enhancing user proficiency and ensuring seamless system utilization., Vendor Management and Patch Application: Managed vendor relationships and oversaw system patch application, including timeline identification, script development, and comprehensive user requirement and risk assessment reviews to facilitate smooth upgrades and maintain compliance.
• Business Analyst, EDMS, 08/2017, 12/2018, MasterControl System Administration: Oversaw the MasterControl system, ensuring smooth operation and optimization of electronic document management processes across departments., Software Upgrade Project Management: Spearheaded a major software upgrade project, managing the entire process from planning to execution, resulting in enhanced system functionality and efficiency., Employee Retraining: Successfully retrained a large cohort of company employees (200) for a significant software upgrade, ensuring seamless transition and minimal disruption to workflow., Electronic Document Management Process Development: Developed and implemented electronic document management processes tailored to the specific needs of various departments, improving organizational efficiency and compliance., Training Process Enhancement: Enhanced the overall training process by developing job codes and training courses, streamlining employee onboarding and skill development efforts., Leadership in Data Governance: Took the lead in data governance initiatives, ensuring data integrity, security, and compliance across the organization.
• Document Control Coordinator, 12/2014, 08/2017, MasterControl Document Change Control Facilitation: Orchestrated the document change control process within MasterControl (EDMS), ensuring seamless transitions and compliance with regulatory standards., Process Improvement Initiatives: Spearheaded the creation and implementation of departmental process improvements, enhancing operational efficiency and effectiveness., Training Coordination and Maintenance: Took charge as the training coordinator, creating and managing Document Control training courses in MasterControl, ensuring workforce competency and adherence to procedures., Metrics Generation and Reporting: Generated comprehensive metrics and reports for management review, providing valuable insights for strategic decision-making and process optimization., Support for Document Management Software Transition: Provided crucial support during the transition from paper to electronic document management software, specifically MasterControl, ensuring a smooth and successful migration., Task Delegation and Team Coordination: Effectively delegated tasks to coworkers, fostering collaboration and maximizing team productivity in achieving organizational goals., SOP Editing and Update Responsibility: Held the responsibility for editing and updating company Standard Operating Procedures (SOPs), maintaining accuracy and compliance with industry regulations., Participation in Regulatory Audits and Supplier Management: Actively participated in both internal and external regulatory audits, as well as supplier management activities, ensuring alignment with regulatory requirements and quality standards.
• Packaging and Labeling Technician, 07/2013, 12/2014, Machine Operations and Maintenance Oversight: Managed the operation of the Box Labeler, including labeling all kit boxes for shipment, and reconfiguring the machine for new label sizes, ensuring smooth and efficient production processes., Production Line Setup and Assembly: Led the setup of production lines for kit packaging assembly, ensuring all equipment and materials were prepared and aligned for efficient production runs., Compliance and Documentation Management: Ensured lab areas maintained full compliance with Good Manufacturing Practices (GMP) standards, while also verifying the currency of batch records, Standard Operating Procedures (SOPs), and specifications to uphold quality and regulatory requirements., Process Improvement and Communication Enhancement: Revised Standard Operating Procedures (SOPs) and created various worksheets to enhance departmental communication and streamline processes, improving overall efficiency., Equipment Proficiency and Training: Demonstrated proficiency in operating and troubleshooting departmental equipment, providing training and assistance to team members as needed to ensure operational effectiveness and safety compliance.

• MES Implementation, 02/2024
• MES System Upgrade, 01/2023
• MES Change Control, 2018-2019
• Master of Science, Regulatory Science, Johns Hopkins University, 2018
• ASQ Internal Auditor (ISO 9001:2015) inclusive of ISO 13485:2016 training 2019
• FDI Parachute Packer Award (2017), first recipient: “Recognizes employees who exemplify the highest level in personal accountability and commitment to meeting the needs of internal and external customers.”
• Advanced Leadership Certificates 2016, 2018
• ASQ Lean Kaizen training 2019