Training Coordinator IV

Reports To: Quality Manager
FLSA Status: Exempt

The Training Coordinator IV is responsible for developing, implementing, and continuously improving training programs within a regulated pharmaceutical warehouse environment that supports product storage, sampling, testing, and laboratory operations.

This role partners with Quality, Operations, Laboratory personnel, Environmental Health & Safety (EHS), and site leadership to ensure employees are trained and qualified in accordance with applicable regulatory requirements, standard operating procedures (SOPs), and quality standards. The Training Coordinator IV plays a key role in maintaining inspection readiness by ensuring training records, qualification documentation, and competency assessments remain accurate, compliant, and audit-ready.

• Develop, maintain, and improve site training programs for warehouse, laboratory, and clean room operations.
• Create and manage role-based training matrices and qualification programs.
• Assign and monitor required training within the Learning Management System (LMS).
• Ensure training assignments remain current with procedural and regulatory updates.
• Track training completion and proactively address overdue or missing training.

• Translate regulatory requirements, SOPs, and quality standards into effective training materials.
• Support compliance with:
  • Current Good Manufacturing Practices (cGMP)
  • Good Distribution Practices (GDP)
  • FDA 21 CFR requirements
  • USP standards
  • Data Integrity principles (ALCOA+)
• Maintain audit-ready training documentation and qualification records.

• Coordinate training for:
  • Clean room behavior
  • Gowning qualification
  • Contamination control
  • Sample handling and chain of custody
  • Laboratory documentation
  • Good Documentation Practices
• Coordinate initial qualification, retraining, and periodic competency verification.
• Develop practical assessments, observation checklists, and qualification documentation.

• Design and update:
  • Training presentations
  • Job aids
  • SOP summaries
  • Work instructions
  • Qualification checklists
  • Assessments
  • Learning resources
• Partner with Subject Matter Experts (SMEs) to ensure technical accuracy and compliance.
• Continuously improve training content using audit findings, performance metrics, and employee feedback.

• Conduct training gap analyses related to:
  • New procedures
  • Equipment implementation
  • Process changes
  • Regulatory updates
  • Audit findings
  • Corrective and preventive actions (CAPA)
• Develop remediation plans and evaluate training effectiveness.

• Manage LMS course configuration and curricula.
• Maintain training matrices and reporting dashboards.
• Ensure training records are complete, accurate, and retrievable.
• Support LMS enhancements and system updates as needed.

• Provide guidance and coaching to trainers, supervisors, and subject matter experts.
• Support Train-the-Trainer initiatives.
• Facilitate instructor-led training sessions and workshops.
• Promote a culture of continuous learning and compliance.

• Prepare training documentation for internal and external audits.
• Support regulatory inspections and client audits.
• Participate in deviation investigations, change controls, and CAPA activities related to training.
• Identify opportunities to improve training effectiveness and operational consistency

• Strong understanding of adult learning principles and training program development.
• Experience administering Learning Management Systems (LMS).
• Knowledge of pharmaceutical quality systems and regulatory requirements.
• Familiarity with:
  • cGMP
  • GDP
  • FDA 21 CFR
  • USP
  • Data Integrity (ALCOA+)
• Excellent technical writing skills.
• Strong communication, organization, and project management abilities.
• Advanced Microsoft Office proficiency, particularly Excel.
• Ability to analyze training metrics and identify process improvements.
• Strong critical thinking, problem-solving, and coaching skills.

• Bachelor's degree in Life Sciences, Microbiology, Chemistry, Pharmaceutical Sciences, Quality, Education, or a related field.
• Five or more years of experience in training, quality, pharmaceutical operations, laboratory operations, clean room environments, or another regulated GxP environment.
• Experience supporting:
  • Pharmaceutical manufacturing or distribution
  • Laboratory testing
  • Quality Assurance or Quality Control
  • Regulated…