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Quality Assurance Training Coordinator – GMP

Krystal Biotech · Pittsburgh, PA · Quality function

Employment type

Full-time

Work setting

On-site

Location

Pittsburgh, PA

Schedule

Day shift

Posted

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Job overview

The Quality Assurance Training Coordinator – GMP role is onsite in Pittsburgh, Pennsylvania. Compensation is not specified. Krystal Biotech develops and manufactures genetic medicines for diseases with high unmet medical needs and supports its quality function through this position. The coordinator administers training systems and supports cross-functional compliance with company policies, cGMPs, and other regulatory requirements. The role maintains training materials, assignments, records, and metrics; supports investigations and corrective actions; and helps prepare training documentation for inspections.

What you'll do

  • Administer the GMP program and Learning Management System
  • maintain knowledge of regulatory guidelines
  • develop and update training materials
  • coordinate annual GMP and GDP training
  • administer SOP and policy training schedules
  • manage training assignments, completion, overdue items, records, and metrics
  • support investigations and CAPAs related to training
  • review curricula
  • retrieve records and respond to inspection documentation requests.

What we're looking for

Skills & competencies
quality assurance training coordinator
gmp
pittsburgh pa
krystal biotech
learning management system
veeva preferred
cgmp compliance
training records
training metrics
capa support
inspection readiness
life sciences
cross-functional quality
Work arrangement
  • Weekend coverage required

Why this role

Supports inspection readiness and training compliance across Quality Assurance, Manufacturing, Quality Control, Facilities, and Supply Chain.

About the employer

Krystal Biotech is hiring for this role. Industry: Biological Product (except Diagnostic) Manufacturing. Sector: 32.

Additional details

Industry sector
32
Industry
Biological Product (except Diagnostic) Manufacturing
Occupation code
13-1151.00
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