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Training Coordinator - Production
Job in
West Columbia, Lexington County, South Carolina, 29172, USA
Listed on 2026-01-12
Listing for:
Nephron Pharmaceuticals
Full Time
position Listed on 2026-01-12
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst
Job Description & How to Apply Below
Nephron Pharmaceuticals
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- 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.
- Understanding of Good Manufacturing Practices (GMP) and aseptic manufacturing requirements.
- Knowledge of training principles, adult learning techniques, and…
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