Kellee N. Herbert

Support artwork and labeling processes for OTC products. The responsibilities include the review and approval of all documentation requiring quality approval SME and approval of Change Controls, review and approvals of Bill of Material (BoMs) and Finished Good specifications, and the creation, review and approvals of Decorated Component Specifications for labeling and artwork OTC projects.

Additional responsibilities are supporting Purchasing Control activities for indirect suppliers, and supporting the Product Sample Process to gain approval to distribute sample of products marketed by our company to consumers and healthcare professionals.

• Implement Purchasing Controls procedure for Consumer US Self Care indirect suppliers
• Lead Self Care implementation activities for indirect supplier and GAP assessment for Home Office
• Responsible for reviewing and approving Over The Counter (OTC) Labeling and Packaging Bill of Material
• McNeil Consumer Healthcare Division, Fort Washington, PA

• Lead and implemented Quality improvement projects, identified opportunities, and drove efficiency in base business work within Quality Systems department.
• Created and implemented validated GMP Spreadsheet tracker to monitor and control Fort Washington Plant (FWP) logbooks
• Reduced 10% of total number of FWP logbooks through validated GMP spreadsheet tracker
• Facilitated aging document reconciliation initiative, resulting in over a 50 percent reduction in FWP aging protocols and reports.
• Developed a SharePoint site for the FWP to automate logbook requests and to ensure information is accessible and easily retrievable for end users
• Managed HyperCare support on new logbook process to ensure continued and seamless change management
• McNeil Consumer Healthcare Division, Fort Washington, PA

• Reviewed and approved implementation and closure change control request
• Identified inefficiencies to continuously improve Shared Operations processes and procedures
• IT Quality & Compliance Shared Operations, Raritan, NJ

• Compiled IT Quality & Compliance metrics for monthly and quarterly Metrics & Management Reviews
• Provided technical support for data gathering and analysis for all IT Quality & Compliance metrics
• Monitored and reported on action items from monthly Metrics & Management Reviews
• Managed audit remediation action item to ensure successful closure of audit remediation actions via Weekly Dashboard to Quality & Compliance organization
• IT Quality Metrics, Raritan, NJ

• Analyzed Audit Issue data to look for commonality of cause and drove proactive remediation
• Participated in the conduct of internal and vendor audits and assessments for Good Practices (GxP) ensuring the integrity, reliability, and quality of process and systems
• Developed and reported metrics on adherence to compliance requirements and that supported regulatory compliance escalations
• Partnered with team members to ensure timely and effective completion of audit observations
• Facilitated adherence to training requirements and compliance procedures and controls
• ITS Regulatory Compliance, Raritan, NJ

• Managed and tracked 24 in-scope PCs through testing lifecycle from possession of PC to completion of test script
• Managed and organized 3 day training for 25 people, designed to help team implement software protection to approximately 14,000 end users
• Supported with driving 17 test scripts for approval to comply Quality and Compliance standards
• Assisted and administered with the recreation of the project SharePoint site
• Global Program Management, Raritan, NJ

• Lead and managed the application development for 2011 Janssen R&D Award Nomination process which allowed nominations to be completed on an online form, used by 30 members of department
• Sponsored the on-boarding, extension, and off-boarding for 317 R&D IT Contractors
• Collaborated with Global Service and IT Business Partners to build project requirements and strategies
• Global Service- Research & Development, Raritan, NJ