Quality Assurance Training Coordinator – GMP
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 coordinatorgmppittsburgh pakrystal biotechlearning management systemveeva preferredcgmp compliancetraining recordstraining metricscapa supportinspection readinesslife sciencescross-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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Listing ID: 8d57a5d8-3ee3-4c44-97b1-65a1f3759e31