About the job
The Aseptic Manufacturing Training Lead plays a pivotal role in the design, delivery, and implementation of training programs tailored for team members in the aseptic manufacturing department. This position is also responsible for maintaining up-to-date employee training profiles within the training system, organizing training records, investigating any delays in training events, and reviewing updates to training-related documentation. The lead ensures adherence to both external and internal AbbVie policies and procedures that govern the training program for the department. Collaborating with cross-functional teams, this role guarantees uniform training practices across operations. Additionally, the lead spearheads continuous improvement initiatives aimed at enhancing training delivery and effectiveness, while exploring innovative technologies to elevate the training experience.
Key Responsibilities
- Implement AbbVie Training Policy, processes, and regulatory training requirements at the site.
- Provide training to both new and existing employees on appropriate cleanroom behavior and best practices, including equipment intervention and sampling.
- Support the implementation of global Aseptic Best Practices related to aseptic processes and training.
- Identify opportunities for improvement within current aseptic processes at the site and manage ongoing improvement projects.
- Observe employee aseptic gowning techniques and provide constructive coaching.
- Conduct Gowning Training for initial certification and recertification.
- Collaborate with Microbiology and Operations for Environmental Monitoring and Sanitization Training.
- Facilitate monthly shift touchpoints focusing on a pre-established rolling Aseptic refresher (targeting 15-20 minutes across 10 topics, conducted when semi-annual refresher training is not performed).
- Conduct monthly Gemba walks with Aseptic MQA and site leadership.
- Dedicate 20% of time to Aseptic Auditing.
- Work with global Aseptic Trainers to develop and deliver targeted aseptic training based on site-specific needs.
- This role supports the entire site for aseptic training, collaborating with global staff to identify and implement additional training as required. Gemba walks and on-the-floor training reinforcement are key components.
- Coordinate training schedules with department supervisors and subject matter experts for complex methods and techniques.
- Maintain training profiles for all trainees, ensuring completed and verified training is entered into the training system and training records are properly filed.
- Conduct periodic reviews and updates of training-related documentation as necessary.
- May provide hands-on training for both basic and advanced skills and techniques.