Senior Training Coordinator - GMP Compliance & Readiness

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

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.