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.

• 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

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.