Designated Trainer Assignment

SUMMARY The Designated Trainer assignment is an additional role granted to an employee who has successfully completed the Designated Trainer certification process in accordance with GLB-TRN-SOP-277. Once certified, the Designated Trainer is authorized, within their assigned operational area, to train, evaluate, and verify personnel process knowledge and task performance in accordance with approved SOPs, work instructions, Quality Management System requirements, GDP expectations, safety standards, customer-specific requirements, and company policies.

KEY RESPONSIBILITIES

• Provide training to employees within assigned certified processes and operational areas.
• Instruct employees on warehouse operations, SOPs, work instructions, quality expectations, and safety requirements.
• Demonstrate proper execution of assigned operational tasks in accordance with approved SOPs and work instructions.
• Train, evaluate, and verify personnel process knowledge and task performance in accordance with approved SOPs, controlled checklists, and QMS requirements.
• Observe trainee progress and offer coaching, feedback, and corrective guidance when needed.
• Assess employee competency through observation, skills checks, and training verification activities.
• Complete and sign required training documentation accurately and timely, and route documentation for review, approval, and retention in accordance with the QMS.
• Support compliance with FDA regulations, GDP standards, customer requirements, approved SOPs, and company policies.
• Identify and communicate potential process, SOP, training, quality, or safety gaps to supervision and/or the Training Coordinator for appropriate escalation, including deviation or change control when applicable.
• Serve as a subject matter resource and model expected standards for quality, safety, compliance, and operational performance.
• Support training activities within assigned certified operational areas as needed.
• Help communicate process updates and support the rollout of new procedures and systems.
• Perform Designated Trainer duties only for assigned processes, SOPs, and operational areas for which certification has been granted.

QUALIFICATIONS

• Minimum of six months as a full-time employee.
• No attendance points within the previous ninety days.
• No active disciplinary actions within the previous ninety days.
• Completion of applicable SOP and controlled training for the assigned work area.

SELECTION CRITERIA

Meets all certification requirements defined in GLB-TRN-SOP-277, including required SOP/controlled document training, comprehension assessments, hands-on performance observation, use of approved process checklists, satisfactory performance scoring, zero unresolved critical-step failures, and final approval by the Training Supervisor/designee.

CONTINUING ASSIGNMENT REQUIREMENTS

Continued assignment as a Designated Trainer is dependent upon maintaining current training status, continued acceptable performance, annual recertification, and compliance with applicable SOPs, quality standards, safety requirements, and company expectations. Requalification or retraining may be required due to prolonged absence of 90 days or longer, SOP revisions, process changes, new equipment or systems, deviations/errors, audit findings, or identified performance gaps.

EVALUATION OF PERFORMANCE

• Successful completion and maintenance of required DT certification activities.
• Demonstrated process knowledge and accurate execution of assigned tasks.
• Adherence to approved SOPs, controlled checklists, safety requirements, and Quality Standards.
• Accurate, complete, and timely completion of required training documentation.
• Effective support of learner understanding and competency development.
• Current training status, deviation/error trends, time to competency for trainees, and retraining frequency.
• Professionalism, adaptability to learner needs, and alignment with company culture and values.

DISCLAIMER This addendum is not intended to replace the employee's primary job description. It outlines the additional expectations, qualification requirements, and responsibilities associated with serving in the Designated Trainer assignment.