Position Summary

Lead, mentor, develop, implement, administer and continuously improve the training program for ADMA Biologics. Ensure that the training program is fully implemented at all levels of the organization.

Essential Functions (ES) and Responsibilities

• Promote a culture of quality and operational excellence and ensuring the advancement of the company’s mission and values.
• Utilize adult learning principles to design, create and develop learning solutions to meet learning objectives and accommodate a variety of learning styles.
• Develop and deliver engaging learning solutions that produce the desired outcomes in responding to the learners needs, including hybrid learning through a variety of media (i.e. videos, power points, demonstrations, etc.) Must possess experience in Camtasia, Adobe Premiere Pro, etc.)
• Lead training team members in critical thinking problem solving. Lead in creating, scheduling, and facilitating training the centralized site-wide cGMP training program for all Boca Raton cGMP staff, including site wide annual training.
• Develop and facilitate training and development, learning initiatives, and training curriculum for specific roles and departments.
• Perform gap analyses to identify opportunities to continuously improve the training program and evaluate effectiveness of training programs to address areas of deficiency (as needed).
• Review and improve standard operating procedures and training programs used in the manufacturing and quality control areas.
• Assist other functional areas in developing training materials associated with departmental SOPs.
• Coordinate and lead cGMP training program, ensuring all employees receive required training, including instructor led training.
• Provide feedback, where appropriate, to departments to ensure full compliance with established procedures and processes.
• Oversee job-specific departmental training to ensure program appropriateness and compliance. Assess programs for effectiveness and initiate improvement plans where necessary.
• Lead initiatives in improving training programs across the company including but not limited to corporate, business and manufacturing areas.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

Minimum of 5-7 years’ experience in Manufacturing, Compliance, Quality Assurance or Quality Control, with at least 2 years leading training initiatives and continuous improvement in an FDA regulated environment.

Preferred Experience

Master’s degree preferred.

Compliance Requirements (ES)

• As a part of our Compliance and cGMP initiatives, employees are responsible for ensuring compliance with all ADMA Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Compliance, Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as Compliance, QA, HR, or EH&S depending on the issue.
• Requires maintaining integrity of timelines to successful completion. Negotiating and resolving interpretations regarding application of ADMA and regulatory agency requirements.