Quality Assurance Training Lead

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

Job summary

Krystal Biotech, Inc. is seeking a highly motivated Quality Assurance Training Coordinator to administer and optimize training systems while supporting the QA function.

The role focuses on cross-functional compliance with company policies, cGMPs, and regulatory requirements to ensure employees are proficient in GMP concepts. You will develop and update GMP training materials, coordinate annual GMP and GDP training, and manage training schedules, records, and metrics across QA, Manufacturing, QC,

Qualifications

• Bachelor's degree in life sciences or technical field, or equivalent experience.
• 2+ years of professional training or development experience.
• Experience with Veeva Training Vault preferred.
• Biopharmaceutical industry experience with cGXP understanding is highly preferred.
• Highly organized, detail oriented, and able to think strategically and meet deadlines.

Responsibilities

• Administer and maintain GMP program and Learning Management System; Veeva experience preferred.
• Develop training programs to ensure compliance with cGMPs and regulatory requirements.
• Collaborate with QA, Manufacturing, QC, Facilities, and Supply Chain.
• Create and update GMP training materials for new hires and staff; assist with group training.
• Coordinate annual GMP and GDP training and manage SOP-based training schedules.
• Maintain training records, metrics, and reporting; monitor completion and overdue training.
• Assign training by roles and curricula; escalate overdue items as needed.
• Support investigations and CAPAs related to training deficiencies or system issues.
• Assist with inspections by providing training records and acting as SME.

Skills

Training coordination

Regulatory knowledge

Cross-functional collaboration

Documentation management

Education

Bachelor's degree in life sciences or technical field

Tools

Veeva Training Vault

Job description

Krystal Biotech, Inc. is seeking a highly motivated Quality Assurance Training Coordinator to administer and optimize training systems while supporting the QA function.

The role focuses on cross-functional compliance with company policies, cGMPs, and regulatory requirements to ensure employees are proficient in GMP concepts. You will develop and update GMP training materials, coordinate annual GMP and GDP training, and manage training schedules, records, and metrics across QA, Manufacturing, QC,