Training Coordinator - Production

NEPHRON SC, LLC•West Columbia, SC

About The Position

Job Purpose: The Training Coordinator – Production provides administrative coordination and support for Good Manufacturing Practice (GMP) training programs within Production Operations. This role ensures accurate scheduling, documentation, tracking, and reporting of GMP-required training to support compliance with regulatory standards and internal quality systems. Working under the Quality & Training function, the Training Coordinator partners with Production and Quality teams to maintain complete, audit-ready training records and support consistent workforce qualification. Essential Duties and Responsibilities: Training Program Development & Delivery: Ø Coordinate and support GMP training activities for Production Operations, including onboarding, initial qualification, certifications, requalification, and ongoing training. Ø Schedule and track instructor-led, on-the-job, and electronic GMP training to ensure timely completion and compliance. Ø Maintain accurate, complete, and audit-ready training records in the Learning Management System (LMS) and other quality systems. Ø Ensure training documentation complies with GMP, regulatory, and internal quality requirements. Ø Coordinate with Subject Matter Experts (SMEs), supervisors, and trainers to ensure training curricula align with current SOPs, work instructions, and controlled documents. Ø Support Production and Quality teams during audits and inspections by providing training records and documentation as requested. Ø Communicate training requirements, schedules, and completion status to Production personnel and management. Ø Support continuous improvement initiatives related to training administration, tracking, and reporting. On-the-Floor Training Support: Ø Provide on-the-floor support for GMP and production training activities, including coordination of on-the-job training (OJT) and task qualification. Ø Actively engage with operators and technicians in ISO 5 and ISO 7 environments, reinforcing aseptic practices and troubleshooting techniques during production runs. Ø Provide on-the-floor training support for aseptic operations, including gowning qualification, aseptic technique, and behavior in classified areas. Ø Verify completion of on-the-floor training sign-offs and ensure accurate documentation of trainer and trainee acknowledgements. Ø Assist with training logistics on the floor, including training materials, controlled documents, and access to required systems or equipment. Ø Escalate identified training gaps, documentation issues, or GMP compliance concerns to Quality and Training leadership. Compliance & Documentation: Ø Ensure GMP training documentation is accurate, complete, and maintained in compliance with regulatory requirements, site procedures, and quality systems. Ø Support audit and inspection readiness by maintaining traceable training records and promptly providing documentation to Quality and regulatory inspectors. Ø Support investigations by providing training-related documentation during deviation reviews and root cause analyses. Ø Monitor training completion, qualification status, and retraining requirements to ensure ongoing compliance and timely remediation of gaps. Performance Monitoring & Reporting: Ø Monitor GMP, aseptic, and production training completion, qualification status, and retraining requirements to ensure ongoing compliance. Ø Maintain training metrics and dashboards, including completion rates, overdue training, and certification status for Production personnel. Employee Development & Engagement: Ø Foster a learning culture by encouraging continuous skill development, cross-training, and professional growth across departments. Ø Establish a feedback loop by gathering insights from trainees and operational leads to improve future training sessions. Ø Provide feedback and guidance to employees during on-the-floor training to encourage adherence to safe practices and quality standards. Supplemental Functions: Ø Perform other training-related duties as assigned.

Requirements

Understanding of Good Manufacturing Practices (GMP) and aseptic manufacturing requirements.
Knowledge of training principles, adult learning techniques, and on-the-job training coordination.
Understanding of production operations, SOPs, work instructions, and process flows in a manufacturing environment.
Awareness of regulatory requirements applicable to production and training (e.g., FDA, EMA, ISO, Annex 1).
Knowledge of training recordkeeping, reporting systems, and data integrity requirements.
Bachelor’s degree in a relevant field (e.g., technical training, pharmaceutical sciences) preferred.
1–3 years of experience in training coordination, production operations, or quality systems within a GMP-regulated environment.
Ability to stand for extended periods, lift and carry equipment up to 50 lbs, and work in sterile, cleanroom environments.
Comfortable wearing required PPE (sterile gloves, gowns, masks, goggles) and working in ISO 5 and ISO 7 environments.
Willingness to work flexible hours, including shift rotations, to support training needs across production operations.

Nice To Haves

Experience supporting on-the-floor training, documentation, and compliance activities in manufacturing or aseptic operations is highly preferred.
Experience supporting audits, inspections, or regulatory documentation is a plus.
Certification in instructional design, adult learning, or technical training preferred.
Lean Manufacturing, Six Sigma, or similar process improvement certifications are a plus.

Responsibilities

Coordinate and support GMP training activities for Production Operations, including onboarding, initial qualification, certifications, requalification, and ongoing training.
Schedule and track instructor-led, on-the-job, and electronic GMP training to ensure timely completion and compliance.
Maintain accurate, complete, and audit-ready training records in the Learning Management System (LMS) and other quality systems.
Ensure training documentation complies with GMP, regulatory, and internal quality requirements.
Coordinate with Subject Matter Experts (SMEs), supervisors, and trainers to ensure training curricula align with current SOPs, work instructions, and controlled documents.
Support Production and Quality teams during audits and inspections by providing training records and documentation as requested.
Communicate training requirements, schedules, and completion status to Production personnel and management.
Support continuous improvement initiatives related to training administration, tracking, and reporting.
Provide on-the-floor support for GMP and production training activities, including coordination of on-the-job training (OJT) and task qualification.
Actively engage with operators and technicians in ISO 5 and ISO 7 environments, reinforcing aseptic practices and troubleshooting techniques during production runs.
Provide on-the-floor training support for aseptic operations, including gowning qualification, aseptic technique, and behavior in classified areas.
Verify completion of on-the-floor training sign-offs and ensure accurate documentation of trainer and trainee acknowledgements.
Assist with training logistics on the floor, including training materials, controlled documents, and access to required systems or equipment.
Escalate identified training gaps, documentation issues, or GMP compliance concerns to Quality and Training leadership.
Ensure GMP training documentation is accurate, complete, and maintained in compliance with regulatory requirements, site procedures, and quality systems.
Support audit and inspection readiness by maintaining traceable training records and promptly providing documentation to Quality and regulatory inspectors.
Support investigations by providing training-related documentation during deviation reviews and root cause analyses.
Monitor training completion, qualification status, and retraining requirements to ensure ongoing compliance and timely remediation of gaps.
Monitor GMP, aseptic, and production training completion, qualification status, and retraining requirements to ensure ongoing compliance.
Maintain training metrics and dashboards, including completion rates, overdue training, and certification status for Production personnel.
Foster a learning culture by encouraging continuous skill development, cross-training, and professional growth across departments.
Establish a feedback loop by gathering insights from trainees and operational leads to improve future training sessions.
Provide feedback and guidance to employees during on-the-floor training to encourage adherence to safe practices and quality standards.
Perform other training-related duties as assigned.