Trainer (Regulated Industry)

NorthStar is a fast-growing company making our way as a new entrant in the medical radioisotope industry. Our mission is to Transform Medical Radioisotopes through ground-breaking technology being developed at our national headquarters in southern WI.

NorthStar is searching for a Trainer to take responsibility for developing content and presenting training programs across the company to all employees, consultants, and product end users. They must employ a thorough understanding of current best practices in training adult learners and demonstrated success in teaching in a regulated manufacturing environment. The Trainer is responsible for training that addresses organizational needs for technical support, regulatory compliance, quality, manufacturing, and safety standards. They also will assist with administration of an electronic training system.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:

1. Work with subject matter experts to design, develop, and implement effective training programs on internally-focused topics such as onboarding, safety, current Good Manufacturing Practices (cGMP), Quality System Regulations, and Good Documentation Practices (GDP) for employees, consultants, and product end users.
2. Develop performance checklist, exams, and worksheets to evaluate training effectiveness.
3. Administer and train personnel in the electronic Quality Management System (eQMS).
4. Assist with training reports, data entry, and security of training records as needed.
5. Assist with development and delivery of current or new training programs, i.e., Train-the-Trainer, Onboarding, Medical Isotope Training, Field Service Engineer Training, RadioGenix User Training, cGMP, customer training, safety training, etc.
6. Assist with development and implementation of training programs outside of compliance, i.e., soft skills, leadership, teambuilding, Lean Six Sigma, supervisory skills, sales, computer software, human resources, and industry knowledge.
7. Work with Service, Customer Contact Center, Sales, and product end users to continually develop and implement technical training.
8. Work with SMEs to create curriculums using the latest technology for instructional design.
9. Assist with training issues when the Training Manager is not available.
10. Assist with response to audit findings or CAPAs dealing with training issues.
11. Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
12. Support NorthStar’s Quality System and Health & Safety Program by following policies and procedures.

Ability and willingness to travel up to 10% of the time.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor’s degree in Education, Instructional Design or Technology, Adult Learning or related subject and three years of experience in training development or equivalent combination of education and experience. Experience with presentation and teaching in a regulated manufacturing environment is required. Experience in pharmaceutical, medical device or nuclear medicine industry is preferred.

Advanced knowledge of Microsoft Office software programs, including Word, Excel, and PowerPoint. Advanced knowledge of eQMS systems for training is preferred. Advanced instructional design work is preferred including computer-based training development.

• Excellent communication skills, verbal and written
• Able to influence people without direct authority
• Ability to hand multiple projects simultaneously
• Able to work independently to complete projects on time
• Adaptable to change in the work environment
• Ability to solve complex problems that affect multiple training areas across the enterprise
• Ability to edit and create training materials
• Demonstrated strong attention to detail

If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.



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