GMP Training Specialist
Draft, revise, or develop training procedure manuals, job aids, SOPs, or course material such as handouts and visual materials. Embeds in training design and delivery GMP practices, and an explanation of WHY. Programs to include but not limited to Investigations, Root Cause Analysis, Train the Trainer, On the Job Training. Possesses the knowledge of adult learning theory, training delivery and how to meet the needs of the learner.
Utilize metrics to establish the success or outcome of the training (# deviations, human error).
Has good interpersonal skills and works interdepartmentally in an effective manner to implement new processes, equipment, changes, root-cause analysis and data/metrics evaluations.
Ability to drive the behavior to follow controlled documents and create a GMP culture. Is passionate for training and to train others.
Strong /detailed knowledge and understanding of biopharmaceutical manufacturing process, related equipment and purpose and function of supporting processes.
Interact with auditors to explain company training policies, materials and manage training related compliance responses.
Conduct orientation sessions and arrange on-the-job training for new hires.
Develop on-the-job training programs for various departments at the site.
Work with Learning Management Systems.
· Manage regular review of curriculum and curriculum owners.
· Conduct follow up sessions on SOP Training as needed and when SOPs are changed; and conduct annual training on GMP guidelines.
Experience & Education:
Life Science Bachelor’s degree and 4+ years of experience within the biologic or pharmaceutical industry with responsibilities for performing, developing or delivering training to colleagues.
Familiarity with electronic systems, including eLMS , MS Office Suite
Excellent written and verbal communication skills
Train the trainer experience is required
Commercial GMP Experience required
GMP: 3 years (Preferred)
eLMS: 3 years (Preferred)
Manufacturing: 5 years (Preferred)
Training: 3 years (Preferred)
FDA: 3 years (Preferred)
Bachelor’s (Preferred) or higher
Source: Job Diva – Job Listing