Senior Pharma Training Coordinator (GMP/LMS)

Technology Transfer Services

Whitestown (IN)

On-site

USD 85,000 - 120,000

Full time

4 hours ago
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Job summary

Technology Transfer Services seeks an experienced Training Coordinator IV to oversee and improve training programs in a regulated pharmaceutical warehouse and distribution setting.

The role focuses on developing, coordinating, and maintaining compliant training for storage, cleanroom operations, sampling, and lab testing, with close collaboration across Quality, Operations, Laboratory, and EHS teams.

Qualifications

  • Minimum 5+ years in training and development in pharmaceutical quality.
  • Bachelor's degree in Life Sciences or related field.
  • Experience in pharma, biotech, lab testing, or regulated distribution.
  • Strong knowledge of cGMP/GDP, FDA, 21 CFR, USP.
  • Experience administering LMS/QMS and developing role-based programs.
  • Proficiency in Excel, data analysis, and training metrics.

Responsibilities

  • Develop, implement, and maintain comprehensive training programs for pharma warehouse, cleanroom, sampling, and laboratory operations.
  • Create and manage role-specific training matrices, curricula, qualification programs, and competency assessments.
  • Coordinate onboarding, ongoing training, refresher courses, and qualification requirements.
  • Ensure training assignments align with job responsibilities, SOPs, and regulatory requirements.
  • Collaborate with cross-functional teams to identify training needs and improve training effectiveness.
  • Develop and coordinate training programs aligned with cGMP/GDP, FDA, 21 CFR, USP, and regulatory standards.
  • Maintain training records within LMS and QMS, manage course assignments and completion tracking.
  • Develop training reports, dashboards, and compliance metrics for leadership review.
  • Develop technical training materials, SOP summaries, job aids, and competency assessments.
  • Partner with subject matter experts to reflect current procedures and regulatory requirements.
  • Conduct training needs assessments and gap analyses to identify opportunities for improvement.
  • Develop corrective training plans and evaluate training effectiveness.
  • Support continuous improvement to strengthen employee competency and compliance.
  • Prepare and present training documentation during audits and inspections.

Skills

Training program development
LMS administration
Regulatory compliance
GxP knowledge
Documentation
Cross-functional collaboration
Quality systems

Education

Bachelor's degree in Life Sciences or related field

Tools

LMS/QMS platforms

Job description

Technology Transfer Services seeks an experienced Training Coordinator IV to oversee and improve training programs in a regulated pharmaceutical warehouse and distribution setting.

The role focuses on developing, coordinating, and maintaining compliant training for storage, cleanroom operations, sampling, and lab testing, with close collaboration across Quality, Operations, Laboratory, and EHS teams.

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