Who we are…
We are a team of scientists, engineers, technicians, and innovators dedicated to changing the world by developing medical isotopes to treat and eradicate cancer. We believe in building an environment where collaboration, curiosity, and camaraderie thrive. We also enjoy darts, cornhole, ping-pong, chili cook-offs, and other fun events that makes our company a community where we make a life, not just a living.
Who you are…
You are a highly organized, detail-oriented professional who thrives in structured, regulated environments. You take pride in creating systems that ensure accuracy, compliance, and consistency. You are a proactive problem solver who anticipates needs, follows through on commitments, and keeps things running smoothly behind the scenes.
You enjoy supporting others and collaborating across teams to ensure people have the training and resources they need to succeed. You are comfortable managing multiple priorities, working with data, and maintaining high-quality documentation. Words that describe you include dependable, meticulous, collaborative, adaptable, and process-driven.
What you can expect to work on…
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.
- 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
What you need to succeed…
- 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)
Great to have…
- 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)
Other things to know…
- Full-time position
- Niowave’s standard operating hours are Monday – Friday 6:00 a.m. – 6:00 p.m. with production related activities requiring 24/7/365 shifts
- This position will have regular working hours Monday – Friday with an expectation of adjusting working hours outside the standard hours to meet operational requirements
- Niowave has multiple locations within the Lansing area and travel between locations is expected in the role
Please provide a cover letter specifically describing the nature of your background and experience as it relates to this position.
