Job Description

Job Purpose:

Under the leadership of the Director of Training and Development, the Training and Development Coordinator collaborates with operational leaders to design, implement, and deliver comprehensive training programs that ensure compliance with cGMP regulations, enhance employee performance, and support professional growth across all departments. This includes assisting with New Hire Orientation, Boot Camp, On-the-Job Training Certification and Recertifications, Contractor Training, Instructor-Led Courses, Training Webinars, Nephron Qualified Trainer program, and cGMP training. The Training and Development Coordinator develops and delivers training strategies that align with organizational goals, regulatory requirements, and industry best practices.

Essential Duties and Responsibilities:

• Assist in the design, implementation, and management of all training programs, including New Hire Orientation, Bootcamp, On-the-Job Training (OJT) Certifications, Nephron Qualified Trainer, Contractor Training, Instructor-Led Courses, Webinars, cGMP training, and leadership development, ensuring proper documentation and timely updates.
• Collaborate with department leaders to identify training needs and skill gaps, and develop and refine training plans, materials, and assessments to address role-specific needs, incorporating regulatory updates, process changes, and organizational objectives.
• Develop and deliver engaging training sessions across multiple formats (classroom, virtual, and hands-on), leveraging educational technology (content creation tools, online collaboration tools, simulations and virtual environments, gamification and learning management tools) to enhance clarity, engagement, and accommodate diverse learning .
• Serve as the administrator for the Learning Management System (LMS), Training Dashboards, and Quality Management System, overseeing training documentation, assigning and tracking training completions, managing OJT certifications, and ensuring accurate and timely processing of training records and metrics.
• Collaborate with department leaders to continuously assess training needs and refine training plans, materials, and assessments, to ensure alignment with organizational goals. Conduct a training matrix review as needed to evaluate and update training requirements.
• Collect and analyze training assessments, surveys, employee feedback, and performance metrics to measure program effectiveness, present findings to leadership, and recommend strategies for continuous improvement.
• Oversee the receipt, organization, and filing of all training documentation, ensuring accurate record-keeping and compliance. Maintain and update employee Personal Excellence Reports (PXRs) by organizing, scanning, naming, and filing training records.
• Serve as a resource for all training-related inquiries, including training procedures, Good Documentation Practices (GDP) questions, training requests, and PXR requests. Provide prompt and professional responses to emails while fostering a collaborative, customer-focused environment that supports professional development and continuous learning.
• Conduct regular audits of the training program, including the Training Plan Matrix Review, OJT Certifications, training documents and records, and employee training files and Personal Excellence Reports (PXR), to identify and address deficiencies, ensure document integrity, and maintain regulatory compliance.
• Conduct facility tours for new employees, school field trips, and visitors, delivering informative and engaging presentations aligned with the company mission.

Supplemental Functions:

• Participate in cross-functional projects and initiatives as assigned.
• Foster a learning-focused, team-oriented environment while promoting awareness of FDA oversight and compliance among employees.
• Collaborate in the development and implementation of new training programs as needed to support employe growth and organizational objectives. Assist with coordinating, scheduling, and facilitating training sessions and workshops.

Requirements

Knowledge & Skills:

• In-depth knowledge of cGMP, FDA, and regulatory training requirements.
• Expertise in instructional design, including curriculum development, learning strategies, and adult learning theory.
• Hands-on experience with Learning Management Systems (LMS), training record management, and change management systems.
• Excellent written and verbal communication skills, with the ability to confidently present and lead training sessions to diverse audiences.
• Strong organizational skills with meticulous attention to detail and the ability to manage multiple projects efficiently and simultaneously.
• Proficiency in MS Office Suite (Word, Excel, PowerPoint), SharePoint, Teams, Adobe Acrobat (advanced features), and tools for interactive training creation.
• Ability to assess learning needs, recommend effective learning solutions, facilitate dynamic training sessions, while measuring outcomes for continuous improvement.
• High commitment to quality, exceptional work standards, and customer service-oriented mindset.
• Strong planning and execution abilities, with a capacity to adapt quickly to changing priorities and evolving needs.
• Proven ability to collaborate effectively across functions, contributing to cross-functional projects and organizational change initiatives.
• Ability to manage oneself with integrity, maintain productivity under pressure, and consistently meet department goals and objectives.
• Demonstrates initiative by efficiently completing all tasks and responsibilities, while proactively seeking opportunities to assist team members and contribute to the overall success of the team.
• Demonstrates discretion and sensitivity when handling confidential information.

Education/Experience:

• Bachelor’s degree or equivalent experience in a pharmaceutical or manufacturing environment.
• Minimum of 3 years of experience training and development, preferably in pharmaceutical manufacturing or a regulated industry.

Working Conditions / Physical Requirements:

• Position requires bending, typing, climbing, lifting (up to 40 1bs.), reaching, standing, sitting and walking throughout the facility.
• Standard work hours are Monday through Friday, 8-hour shifts with additional hours as needed based on company demand.