Description

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.

Job Specifications and Qualifications:

Knowledge:

Ø Understanding of Good Manufacturing Practices (GMP) and aseptic manufacturing requirements.

Ø Knowledge of training principles, adult learning techniques, and on-the-job training coordination.

Ø Understanding of production operations, SOPs, work instructions, and process flows in a manufacturing environment.

Ø Awareness of regulatory requirements applicable to production and training (e.g., FDA, EMA, ISO, Annex 1).

Ø Knowledge of training recordkeeping, reporting systems, and data integrity requirements.

Education/Experience:

Ø Bachelor's degree in a relevant field (e.g., technical training, pharmaceutical sciences) preferred.

Ø 13 years of experience in training coordination, production operations, or quality systems within a GMP-regulated environment.

Ø Experience supporting on-the-floor training, documentation, and compliance activities in manufacturing or aseptic operations is highly preferred.

Ø Experience supporting audits, inspections, or regulatory documentation is a plus.

Licensing and Certification:

Ø Certification in instructional design, adult learning, or technical training preferred.

Ø Lean Manufacturing, Six Sigma, or similar process improvement certifications are a plus.

Working Conditions / Physical Requirements:

Ø Ability to stand for extended periods, lift and carry equipment up to 50 lbs, and work in sterile, cleanroom environments.

Ø Comfortable wearing required PPE (sterile gloves, gowns, masks, goggles) and working in ISO 5 and ISO 7 environments.

Ø Willingness to work flexible hours, including shift rotations, to support training needs across  production operations.

Salary: Based on experience.

PI280874524