GMP QA Training & Compliance Coordinator

Krystal Biotech; Pittsburgh (Allegheny County); On-site; USD 70,000 - 100,000; Full time

Job summary

Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Assurance Training Coordinator to administer, maintain and execute training systems in support of the Quality function.

This role focuses on cross-functional compliance with cGMPs and other regulatory requirements, and includes developing GMP training materials and maintaining training records. The position requires coordinating GMP and GDP training, maintaining LMS systems, and collaborating with QA, Manufacturing, QC,

Qualifications

• Bachelor’s degree in life sciences or related field.
• 2+ years in training or development capacity.
• Experience with electronic training systems such as Veeva.
• Biopharma experience and understanding of cGXP’s.
• Strong organizational and communication skills.

Responsibilities

• Administer GMP program and LMS; Veeva experience preferred.
• Develop training programs on cGMPs and regulations.
• Coordinate GMP and GDP training annually.
• Maintain training records and metrics.
• Collaborate with QA, Manufacturing, QC, Facilities, and Supply Chain.
• Support inspections and provide training SME during audits.
• Generate training metrics and oversee overdue training.
• Assist with CAPAs related to training.
• Ensure training curricula stay current.
• Inform management of deviations and propose solutions.
• Other duties as assigned.

Skills

GMP training

LMS management

Veeva Training Vault

cGMP knowledge

Regulatory compliance

Cross-functional collaboration

Training coordination

SOP development

Documentation skills

Project management

Education

Bachelor’s degree in life sciences

Tools

Veeva Training Vault

Job description

Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Assurance Training Coordinator to administer, maintain and execute training systems in support of the Quality function.

This role focuses on cross-functional compliance with cGMPs and other regulatory requirements, and includes developing GMP training materials and maintaining training records. The position requires coordinating GMP and GDP training, maintaining LMS systems, and collaborating with QA, Manufacturing, QC,