Training Coordinator IV

Stefanini, Inc; Greenfield (IN); On-site; USD 65,000 - 95,000; Full time

Job summary

Stefanini, Inc is seeking a Training Coordinator IV to develop and manage training programs for a regulated pharmaceutical warehouse environment. You will work with Quality, Operations, Laboratory teams and site leadership to ensure training records, competency, and documentation meet regulatory standards.

The role emphasizes audit readiness, CAPA integration, and continuous improvement of training content, assessments, and LMS processes.

Qualifications

• 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 and communication skills.
• Advanced Excel and project management abilities.

Responsibilities

• Develop, maintain, and improve site training programs for warehouse, laboratory, and clean room operations.
• Translate regulatory requirements into training materials and ensure audit-ready records.
• Coordinate training for clean room behavior, gowning, containment, and laboratory documentation.
• Lead LMS configuration, curricula, and reporting; track training completion and gaps.
• Design assessments, checklists, and qualifications; partner with SMEs for accuracy.

Skills

Adult learning principles

LMS administration

Technical writing

Communication & project management

Excel proficiency

Regulatory knowledge (cGMP, GDP, FDA 5

Education

Bachelor's degree in Life Sciences or related field

Job description

Reports To: Quality Manager
FLSA Status: Exempt

Position Summary

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.

Key Responsibilities

Training Program Management

• 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.

Regulatory Compliance

• 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.

Clean Room & Laboratory Training

• 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.

Training Development

• 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.

Training Needs Assessment

• 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.

LMS Administration

• 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.

Leadership & Coaching

• 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.

Audit & Continuous Improvement

• 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

Job Requirements

Qualifications

Required Knowledge & Skills

• 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.

Preferred Experience

• 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 warehouse operations
• Experience with:
  • LMS administration
  • Curriculum development
  • Competency assessments
  • Technical writing
  • Audit readiness
  • CAPA and Change Control processes

Preferred Certifications

• Train-the-Trainer
• ASQ Certifications
• GMP Certification
• Data Integrity Training
• OSHA
• HazMat
• DOT/49 CFR
• PIT Trainer (where applicable)

Physical Requirements

• Ability to work with computers, LMS platforms, office equipment, and training technology.
• Ability to walk warehouse and laboratory areas as needed.
• Must be able to comply with PPE, gowning, hygiene, and clean room requirements.
• Ability to stand, walk, sit, and occasionally lift training materials.

This position supports operations in office, warehouse, laboratory, and clean room environments. The role requires collaboration across Quality, Operations, EHS, and leadership teams and may occasionally require travel to support additional facilities.