Lead Professional Education Coordinator

Role Summary

Lead Professional Education Coordinator develops trainees into qualified associates by delivering hands-on training and coordinating production training programs. The role leads manufacturing training activities, ensures adherence to cGMP, and promotes environmental health and safety throughout production. The position requires technical and administrative competence to organize and lead training, and to write or revise SOPs and training materials as needed.

Responsibilities

• Provide on the job training and assisting with e-learning requirements.
• Analyze training needs, monitor training compliance
• Provide constructive feedback and coaching to associates.
• Perform hands-on execution of manufacturing operations to support production schedule as needed.
• Identify training gaps and developing a strategy to close them.
• Anticipate problems or opportunities and implement proactive solutions.
• May be required to write or revise SOPs, Job Aids, Knowledge Assessment and Skills Assessments.
• Contribute toward authoring SOPs, Job aids, and Structured on the Job Training (SOJT) associated to manufacturing processes.
• Provide assistance to other Associates with SOJT and E-Learning requirements.
• Manage and execute training interventions designed to solve specific training problems for either individuals or groups (Investigations, CAPA, Protocols)
• May be required to develop specific training programs to help associates learn sustain and/or improve their job skills.
• Support the implementation of Kaizen, Kanban and 5S systems to assist from CQV to Full production environment. Inform department managers of continuous improvement opportunities.
• Contribute to a culture of safety first in compliance with Environmental, Health, Safety (EHS) through all manufacturing associates and production engineers. Understand and follow Job Hazard Analysis (JHA) packets.
• Train and explain process to others and ensure execution of processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply.

Qualifications

• Required: Must be qualified in at least one process function in Fractionation.
• Preferred: Experience in a regulated environment.
• Required: Must have working knowledge of GxP and training principles.
• Required: Minimum 5 years of relatable/relevant experience.

Education

• High school diploma or equivalent (Required).
• Associate degree (Preferred).

Additional Requirements

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.