Training Coordinator

Niowave Inc.•Lansing, MI

About The Position

The Training Coordinator is responsible for coordinating staff training programs and managing document control processes within a regulated environment. This role ensures training compliance, maintains accurate records, and supports audit readiness while also overseeing controlled documentation practices across the organization. This role supports the Niowave Mission by fostering a culture of continuous learning, operational excellence, and strong documentation practices.

Requirements

Associates’ degree in Life Sciences, Human Resources, Education, or a related field
3+ years of experience in a training or quality role within the pharmaceutical, biotech, or medical device industry
Embraces & models the Niowave Values of Teamwork, Courage, Integrity, and Upright Zeal, Humble, Hungry, and Smart
Develops and maintains good relationships, gains the confidence of others, and works effectively in a multidisciplinary matrix environment
Understands how to integrate into a new team/organization
Appreciates the history of current state of systems and processes and exercises sound judgment in proposing and implementing improvements
Understands personal communication and learning styles and adapts approach to connect effectively with others
Displays excellent interpersonal, written, and oral communication skills
Possesses sound organizational skills
Demonstrated strong ability as a being detail-oriented and a resilient, self-starter
Strong understanding of cGxP regulations and training program requirements in the context of pharmaceutical industry
Proficient computer skills in Microsoft Office, Learning Management Systems, and eLearning software programs (e.g., Articulate, iSpring Suite, Adobe Captivate)

Nice To Haves

Bachelor’s degree in Life Sciences, Human Resources, Education, or a related field
5+ years of experience in a training or quality role within the pharmaceutical, biotech, or medical device industry
Proficiency in instructional design models (e.g., ADDIE, Gagné’s Nine Events of Instruction, Bloom’s Taxonomy)
Experience supporting regulatory inspections (FDA, EMA, etc.)
Previous experience using MasterControl Quality Management System for Training)

Responsibilities

Coordinate and schedule training sessions for new hires, role-specific qualifications, compliance training, and ongoing development
Maintain training curricula aligned with job roles, departmental needs, and regulatory expectations
Track and maintain training records in compliance with FDA, EMA, and other regulatory requirements
Monitor training completion, follow up on overdue assignments, and ensure workforce qualification readiness
Maintain training matrices to ensure employees are properly trained for assigned responsibilities
Partner with subject matter experts and department leaders to identify training needs and support content development
Generate and report training metrics, including completion rates, compliance status, and qualification gaps
Support internal audits, regulatory inspections, and customer audits by providing training documentation
Ensure compliance with documentation standards, including cGMP and ALCOA+ principles
Maintain a centralized library of controlled documents across departments, including policies, procedures, and training materials
Ensure proper version control, approval workflows, and document lifecycle management
Coordinate document reviews and revisions with subject matter experts and department leaders