Kim Belculfine Email & Phone Number

United States

United States

Gaithersburg, Maryland, Us

Gaithersburg, Maryland, Us

Led/Supported the day-to-day operations of the site Training department:• Ensured on-time completion of training assignments, recording of training activities, processing of eService Tickets, and compliance with regulatory expectations.• Trained learning administrators and supported their professional development.• Managed New Hire Orientation program.• Conducted Train-the-Trainer sessions and evaluated new GxP trainers/instructors.• Created and maintained task-based curriculum structure and mentored sites to align globally.• Built and assigned learning plans for all positions by collaborating with department managers.• Designed, developed, and delivered interactive training solutions on GxP topics and business tools using instructional design and appropriate training methodologies.• Identified gaps in training and opportunities to improve a process or employee effectiveness.• Authored SOPs, Job Aids, Work Instructions, reference materials, and templates.

• Directed a team and balanced workload resulting in high quality work meeting project deadlines.• Led the development and maintenance of Quality documents (SOPs, standards, job aids, etc.) including naming/numbering conventions and continuous improvements.• System owner: Configured and administered the learning management and document danagement system (MasterControl).• Performed QA review, editing and issuance of documentation related to GMP production of APIs used in Phase 1 and 2 clinical trials, and interacted with clients for reviews and approvals.• Managed site Records Management program.• Led “Back Room” operations for client audits• Designed and delivered training program curricula and course content.• Reported global and site training performance metrics to site scorecard.

Cambridge, Cambridgeshire, Gb

• System Owner/Administrator of Document Management System and Batch Record System; maintained and updated master batch records for cGMP manufacturing.• Developed/delivered training to system users and administrators and provided continued support.• Led Batch Record launches for new products, continuous improvement projects, and change control supporting US and International markets.• Authored/executed test scripts for Batch Record System upgrades.• Key partner in external and internal audits, inspections (FDA, MPA, Turkish MoH).• Conducted annual documentation review and program audits.• Authored deviations/CAPAs in TrackWise and participated in root cause analysis investigations.Site Maintenance Planning Analyst (Facilities)• Managed SAP Plant Maintenance System/Preventative Maintenance Program• Developed and delivered training for SAP Plant Maintenance modules, document management system, and Good Documentation Practices resulting in reduction in deviations• Member of the Cross-site North American SAP Super-Users Group.• Generated/published KPIs for workload performance and plant maintenance.• Developed and implemented efficiency plan for decommissioning SAP Plant Maintenance system and technical documentation.SHE Administrator (Safety Health & Environment)• Administered Accident/Incident (AI), Safety Data Sheet (SDS) and Chemical Inventory programs; maintained electronic records and Investigation Process in SharePoint.• Developed and delivered SharePoint training and provided ongoing user support.• Organized and led committees to promote a safety culture that is imbedded into daily work life.• Authored and published communications and announcements.• Managed site PPE Program (Personal Protective Equipment) to meet gowning guidelines.