GMP Training Lead, Biotech Quality Assurance

Krystal Biotech

Pittsburgh, Northern (Allegheny County, KY)

Hybrid

USD 70,000 - 95,000

Full time

4 days ago
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Job summary

Krystal Biotech, Inc. is seeking a highly motivated Quality Assurance Training Coordinator to administer and maintain training systems, ensure cross‑functional cGMP compliance, and support the Quality function.

This role focuses on developing GMP and GDP training, maintaining the LMS (Veeva preferred), tracking completion, and collaborating with QA, Manufacturing, QC, Facilities, and Supply Chain to sustain inspection readiness.

Qualifications

  • Bachelor’s degree in life sciences or technical field, or equivalent combination of education and relevant experience.
  • 2+ years of professional experience in a training or developmental capacity; experience with electronic training systems preferred.
  • Experience within biopharmaceutical industry and understanding of cGXP’s.
  • Highly organized and detail oriented with ability to synthesize information and think strategically.
  • Strong communication and stakeholder management skills.

Responsibilities

  • Administer and maintain the GMP program and Learning Management System; experience with Veeva preferred.
  • Develop and update GMP training materials for new hires and existing employees; assist with group training.
  • Coordinate and provide annual GMP and GDP training; monitor training completion and overdue training.
  • Support inspections by retrieving training records and acting as SME for training during inspections.
  • Collaborate with Quality Assurance, Manufacturing, Quality Control, Facilities, and Supply Chain.

Skills

Training coordination
Regulatory understanding
Veeva Training Vault
Documentation management
Stakeholder management

Education

Bachelor’s degree in life sciences or related field

Tools

Veeva Training Vault

Job description

Krystal Biotech, Inc. is seeking a highly motivated Quality Assurance Training Coordinator to administer and maintain training systems, ensure cross‑functional cGMP compliance, and support the Quality function.

This role focuses on developing GMP and GDP training, maintaining the LMS (Veeva preferred), tracking completion, and collaborating with QA, Manufacturing, QC, Facilities, and Supply Chain to sustain inspection readiness.

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