Aseptic Site Trainer

Role Summary

The Aseptic Site Trainer is responsible for assisting in the coordination of delivery of high-quality educational services and solutions. The role provides administrative support in the implementation of training programs and in the ongoing facilitation and tracking of training initiatives and requirements. It involves close collaboration with leaders and associates throughout the organization to ensure educational solutions are accurate, comprehensive, and applicable to business needs.

Responsibilities

• Ensure AbbVie Training Policy, process and procedures and regulatory training requirements are implemented at the site.
• Train new and existing employees on appropriate cleanroom behavior and best practices including activities such as equipment intervention and sampling.
• Support implementation of global Aseptic Best Practices related to aseptic processes and training.
• Create content and administer periodic refresher training for employees working in the cleanroom areas.
• Create and revise procedures related to job function as needed.
• Identify areas of improvement with current aseptic processes at the site and manage continued improvement projects as needed.
• Observe employees' aseptic gowning technique and provide coaching.
• Perform additional aseptic related projects as assigned by department management.
• Maintain a working knowledge of operations processes; actively recommend, support, and facilitate continuous improvement projects to increase training system effectiveness.
• Generate training status tracking reports and present reports to site management.
• Gowning Training (initial and recertification).
• Partner with Microbiology and Operations for Environmental Monitoring and Sanitization Training.
• Monthly shift touchpoints focused on a rolling aseptic refresher (target 15-20 min, 10 topics).
• Monthly Gemba walks with Aseptic MQA / site leadership.
• 20% of time dedicated to Aseptic Auditing.
• Work with global Aseptic Trainers to develop and deliver targeted aseptic trainings based on site needs.
• Support the entire site for aseptic training, collaborating with global staff to identify and roll out additional training as required, including Gemba walks and on-the-floor reinforcement.

Qualifications

• Knowledge of regulations and standards for aseptic manufacturing and application to training.
• At least 3 years of aseptic operations/quality/training experience, combined experience is required.
• Essential experience should include knowledge of GMPs, aseptic manufacturing, and training processes.
• Strong oral and excellent written communication skills; excellent organizational skills.
• Strong computer skills, including Microsoft Windows and Office applications.
• Ability to independently manage multiple tasks/assignments, meet deadlines, and adapt in a dynamic environment with evolving needs.
• Ability to effectively interact and develop constructive relationships with subject matter experts and other business partners.

Education

• Bachelor’s degree required. Degree program or professional certification in Education, Communication, Training, or a related field is beneficial.

Skills

• Communication and collaboration with cross-functional teams.
• Training design, content development, and delivery.
• Documentation, reporting, and presentation of training metrics.