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Accomplished Quality Compliance Lead of site-wide learning programs, curricula design, and training metrics management. Passionate about implementing creative solutions to quality issues. Looking to move into a team leadership role to expand expertise in complex problem solving.
- Advanced global learning management system administrator (SAP SuccessFactors).
- Advanced instructional designer (MS PowerPoint 2016).
- Proficient training metrics analyst (MS Power BI 2016).
- Proficient web designer (MS SharePoint 2016).
- Proficient implementor of written standards.
- Skilled collaborator with cross functional teams.
- Demonstrated knowledge of FDA regulations.
- Continuous study of new technologies in pursuit of solutions to complex issues.
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- Strong verbal and written communicator.
- Lean Sigma white belt certified.
- Instructional designer (Articulate Studio).
- Skilled project manager.
- Subject Matter Expert (SME) for Level 1-4 Audits.
- Skilled presenter for Tier 1 Quality Council.
- Team leader and coach for 3 personnel.
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Sr Data Compliance Lead / Learning Manager, 04/2015 to Current
GlaxoSmithKline (Biopharm Product Develop Supply) – City, STATE,
- Managed 3 indirect staff in administration of training program.
- Created periodic performance metrics measuring status of on-time training completion across manufacturing site.
- Demonstrated leadership by Implementing Power BI dashboards for improved visibility of training compliance across manufacturing site.
- Effectively designed new curricula to support company re-organizations, and implementation of quality systems.
- Led continuous improvement activities for site training program. This included problem solving techniques such as process mapping and cost-time management.
- Analyzed training data in Power BI to identify trends and make recommendations of improved performance to senior management.
- Created site Role-based Training Program, resulting in increased productivity and compliance for over 600 personnel.
- Developed SharePoint information hub to support training and implementation of Veeva Vault document management system.
- Developed user friendly SharePoint site for training requests and assistance, enabling technical support for Learning Management System (LMS) issues.
- Developed new solution in Success Factors (SAP) for tracking leavers from organization. New process streamlined activities for over 100 managers.
- Redesigned site annual review of training using Articulate Studio, resulting in simplification and improved GxP compliance.
Sr Document Compliance Specialist /LMS Administrator, 09/2008 to 04/2015
Glaxosmithkline (BPDS) – City, STATE,
- Blended organization's goals and objectives with learning initiatives to deliver high-quality training program for manufacturing site.
- Developed training materials and SOPs to enable organization's effective use of LMS.
- Coached and trained 25 training coordinators resulting in improved training support across organization.
- Led manufacturing site of 200 personnel in conversion from paper-based to electronic training program.
- Administrated GxP training content, and curricula utilizing LMS.
- Devised high quality eLearning modules using Articulate Studio.
Document Compliance Specialist, 04/2003 to 10/2008
Glaxosmithkline – City, STATE,
- Migrated 5000 procedures from paper to electronic document management system (EDM).
- Managed project team of 2 contract staff to support EDM migration.
- Led site-wide instructor-led training sessions on use of EDM.
- Issued GMP documents (e.g. SOPs, methods, specifications, protocols/reports) through all stages of document life cycle within EDM.
- Issued manufacturing batch records for Phase 1/2 clinical assets.
- Redesigned process for issuance/reconciliation of controlled documents. Significantly improved traceability of GxP records in manufacturing areas.
- Led site-wide upgrade to new electronic document management solution (CDMS).
Associate of Applied Science: Web Development And Design, Expected in 06/2023
Montgomery County Community College - Blue Bell, PA
GPA:
- Java - Programming Concepts (January 2020)
- HTML - Web Design and Development (July 2020)
- Agile Scrum - Applied Software Development (September 2020)
- Photoshop - Visual Communication (September 2020)
- UI / UX Design (January 2021)
- Java - Object Oriented Programming (January 2021)
: Instructional Technology Management, Expected in
La Salle University - Philadelphia, PA
GPA:
- Web Design and Visual Literacy (September 2014)
- Assessment of Learning Programs (January 2015)
Bachelor of Science: General Science, Expected in
Pennsylvania State University - University Park, PA
GPA:
Minor: Biochemistry
- Power BI Essentials (2019); LinkedIn Learning (April 2020)
- Migrating from Classic to Modern SharePoint Sites; LinkedIn Learning (May 2020)
- Project Management Experience; GSK (April 2017)
- Regulatory Inspection Trends and Data Integrity; PDA (April 2016)
- Mastering Deviations and CAPA Management; GSK (July 2015)
- International Training Conference; ATD (May 2012)
- Articulate Studio; Yukon Learning (July 2011)
- Global Employee Recognition Award: Rapid implementation of new safety training in myLearning. Efforts enabled safe return of personnel to site during Covid-19 pandemic.
- Science of Excellence Award: Defined electronic document data properties for migrating to new document management system (CDMS). Efforts allowed for knowledge-sharing within RD.
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