FLSA Status: Exempt
Mon-Fri 7:30a-4:30 pm with flexibility for extended hours as needed
Position Summary
Supervise all shifts of the Compliance Training Department (personnel and daily activities). Subject Mater Expert (SME) and system owner for Training Compliance, iLearning, and integration of the iLearning Learning Management System (LMS). Responsible for the identification, development and implementation of site compliance training needs. Develop and conduct training required for new and existing employees to ensure compliance with policies, procedures, and Current Good Manufacturing Practices (cGMPs). Instructional responsibilities include creation and facilitation of employee development courses. Analyze, report, and troubleshoot employee training records via LMS.
Essential Duties & Responsibilities
- Create and facilitate the development of training modules beyond read/understand using proven training techniques.
- Ensure iLearning curricula and matrices are set up and maintained in a manner that iLearning can be used as both a training tracking system and a personnel development tool.
- Develop proficiency / qualification testing of key facets for the site including iLearning Knowledge Assessment Tools.
- Coordinate and conduct new employee orientation, facilitation skills, train-the-trainer sessions, and other classroom training as needed.
- Develop and train compliance training staff to ensure they possess skills necessary to effectively support site training needs.
- Ensures Training Compliance associated with Change Controls and Document Revisions are completed.
- Maintain awareness of plant programs/processes, and develop, implement, and continuously improve training documentation to ensure regulatory compliance guidelines are met.
- Perform investigations of training-related cGMP/regulation violations, Investigations, and Corrective and Preventative Actions (CA/PAs).
- Other training project responsibilities as required by corporate or regulatory response to evolving regulatory requirement as assigned by area management.
- Report training status metrics for monthly Management Review.
- Perform other related duties as assigned or required.
Knowledge, Skills & Qualifications
- Experience with iLearning or other LMS including training record analysis and reporting.
- Advanced Microsoft Office skills, specifically Microsoft Excel and Power Point.
- Effective written and oral communication skills and technical writing skills.
- Strong analytical skills including critical thinking skills to improve existing training systems/processes.
- Must take initiative and be responsible for projects with minimal management direction.
- Demonstrated experience with creating web-based learning, developing, and implementing training materials with proficiency measurements.
- Must be organized to work within numerous systems and programs.
- Regulatory inspection experience discussing training is preferred.
- Specific skills of Public Speaking / Facilitation, Project Management, and situational leadership are preferred.
Education And Experience
- Must be at least 18 years of age
- Bachelor’s degree from an accredited college or university is required.
- 4 years of training experience required, preferably in an FDA or similarly regulated industry. Previous supervisory experience is also strongly preferred.
Physical Requirements And Work Environment
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Typically requires travel less than 5% of the time
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Quality
Primary Location
US-TX-Austin
Schedule
Full-time
Shift
Day Job
