GMP Training Coordinator — Biotech Quality & Compliance

krystalbiotech; Pittsburgh (Allegheny County); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

Krystal Biotech, a leader in genetic medicines based in Pittsburgh, seeks a Quality Assurance Training Coordinator to administer and maintain training systems in support of the Quality function. You will ensure cross‑functional compliance with cGMPs and regulatory requirements, while developing training programs for employees, contractors and visitors.

Responsibilities include maintaining the GMP program and LMS, coordinating annual GMP/GDP training, tracking training metrics, and supporting

Qualifikationen

• Bachelor’s degree in life sciences or technical field, or equivalent.
• 2+ years in a training or developmental role; Veeva Training Vault preferred.
• Biopharmaceutical industry experience with cGXP knowledge.
• Highly organized, proactive, and able to manage multiple projects.
• Strong communication and stakeholder management skills.

Aufgaben

• Administer and maintain GMP training programs and LMS (Veeva preferred).
• Develop training materials for new hires, employees, contractors, visitors.
• Coordinate annual GMP and GDP training.
• Track training completion and maintain records and metrics.
• Support inspections by providing training records and SME input.
• Collaborate with Quality Assurance, Manufacturing, QC, Facilities, and Supply Chain.

Kenntnisse

Training coordination

Veeva Training Vault

cGXP knowledge

Stakeholder management

Communication skills

Ausbildung

Bachelor's in life sciences

Tools

Veeva Training Vault

Jobbeschreibung

Krystal Biotech, a leader in genetic medicines based in Pittsburgh, seeks a Quality Assurance Training Coordinator to administer and maintain training systems in support of the Quality function. You will ensure cross‑functional compliance with cGMPs and regulatory requirements, while developing training programs for employees, contractors and visitors.

Responsibilities include maintaining the GMP program and LMS, coordinating annual GMP/GDP training, tracking training metrics, and supporting