Derek Hartzell Email and Phone Number

In my current role as Documentation and Training Specialist II, I: • Direct the supporting team for the R&D Manufacturing pilot line; the team comprises technical trainers, maintenance technicians, material coordinators, and molding technicians performing tasks related to calibration, PMs, training, material supplies to the line, and running multiple molding presses. • Prepare and champion the implementation of technical documents for corporate software systems and processes and develop training curricula and resources.• Design training and delivery methods to suit various settings, such as classroom training and video presentations. Analyze training needs and utilize multiple tools, such as surveys and focus groups, to confirm analysis results. • Develop and maintain training-related documents, such as course descriptions, skill assessments, and training risk assessments.• Confirm the effectiveness of implemented training programs through training certification, performance approval, and/or internal audits; recognize opportunities to improve training systems and processes.• Administer the Compliance Wire LMS for all R&D activities (Administrator), implement SOPs, JBS, and ECNs for new product lines, and lead the training of all R&D employees.• Confirm the maintenance of quality standards in production by working with the Manufacturing Manager, Quality Assurance Technicians, and/or Engineer.• Conduct evaluations of all work done and provide feedback regarding performance; manage work assignments, transfers, promotions, and discharges in compliance with company policies.• Assess the work of individual employees, identify high-performing staff, and recommend pay increases. Hire and train new employees for the production line, as needed.

In my previous role as a Pharmaceutical Manufacturing Technical Support & Trainer, I:• Championed the implementation of electronic batch production (BPR) records in multiple production areas, which led to a reduction of over 20% in operator errors compared to paperwork BPRs.• Oversaw the inspection certification process to identify foreign materials in peritoneal dialysis and saline solutions. Established multiple standard operating procedures (SOPs) and on-the-job (OTJ) brochures following good manufacturing practices (GMP).• Chaired the investigation, implementation, and monitoring stages of multiple Corrective and Prevent Action (CAPA) initiatives in two pharmaceutical departments; assisted the departments during US Food and Drug Administration (FDA) audits.• Participated in the development of plans and programs for meeting and maintaining product quality by monitoring operations to prevent the production of defects; confirmed adherence to quality plans and requirements through analysis; investigated adverse quality trends or conditions and initiated corrective action.

In my previous role as Technical Trainer, I: • Coordinated the training personnel program for the company’s manufacturing of pharmaceutical products. Developed outlines and determined the best instructional methods, such as individual or group instruction and demonstrations. • Delivered SOP training, quality training, proper technique, on-the-joining, use of computers and software, and refresher training. Evaluated each production process and oversaw training, reaction time, and company mission capability.• Efficiently directed the daily activities of the training functions; established goals and objectives; reviewed and rewrote training policies, procedures, and mission objectives; and implemented quality improvements.• Designed and created teaching aids such as training handbooks, PowerPoint Presentations, demonstration models, multimedia visual aids, computer tutorials, and reference works for training.• Organized and managed workflows and set and adjusted appropriate priorities to meet organizational and mission needs. • Prepared training materials and coached new and existing personnel using technical references to operate instructions, regulations, policies, procedures, and directives; provided counseling on operating guidelines.• Led the resolution of a broad range of operating and administrative issues; created testing and evaluation procedures to be used after training; evaluated requirements and balanced needs with overall mission requirements.• Completed multiple tasks and ensured personnel was trained and equipped to provide customer support; assessed progress by administering tests and evaluated effective training.

In my previous role as Logistics Clerk, I:• Oversaw all logistics management operations, including planning, coordinating, and evaluating the logistical actions required to support the Fresenius Medical Care program.• Developed and deployed BPR to the manufacturing area to produce dialysis solutions. Evaluated and corrected BPRs to meet GMP criteria required for finished good release.• Confirmed raw materials and finished goods product code, lot number, quantity, and expiration moving in and out of the departments; supervised raw material retesting if it was near expiration.• Administered daily raw materials orders and weekly inventory for two pharmaceutical departments producing dialysis and saline solutions.• Outlined logistics plans for organizational and process structure, training needs, and changing workload based on principles, management objectives, and company policies.• Supervised operations to confirm proper storage methods were complied with to maintain the integrity of the condition of items and equipment, including binning, rotation, temperature control, storage requirements, and material handling practices.• Performed analysis of inventory flow, reductions, and product touches and maintained the accuracy of applicable procedures. Purchased and replaced materials when needed; issued and tracked non-production inventory items.• Closely tracked orders placed, received, and then distributed as per instructions; finalized purchase orders for the department. Analyzed operations periodically and proposed recommendations for improvements.• Requested batch numbers for raw materials according to the expiration (FIFO) and promptly alerted the Production Planner when necessary.

In my previous role as Sustaining Engineering, Sr. Technician & Special Projects, I:• Assisted Sr. Engineers and R&D scientists in multiple projects, including E-beam sterilization, new injection ports, connectors, and reusable cases for pharmaceutical products. • Worked closely with colleagues to brainstorm and develop ideas for new products and changes to existing products.• Identified risks and took corrective actions to maintain compliance with customer service and contractual expectations. Developed documents for product builds in all phases of the product development cycle.• Championed the development of program goals and objectives related to customers’ business strategies and long-term needs; led program assessment, team building, schedule preparation, status and jeopardy reports, risk analysis, and program status.• Leveraged expertise in standards and methods work to plan and conduct industrial engineering studies, which were extensive in scope, covering all production shops within the company.• Managed the participation of all required internal and external resources and partnered with subordinate organizational Sustaining Engineers and Program Management.