GMP Document Control & QA Associate

Krystal Biotech, Inc.; Coraopolis (Allegheny County); On-site; USD 65,000 - 95,000; Full time

Job summary

Krystal Biotech, Inc is seeking a highly organized Quality Assurance Document Control Associate to support the implementation of quality and document control systems. The role will ensure compliance with internal procedures, cGMPs, and regulatory requirements within GMP manufacturing and QC labs.

This position is based at the Astra facility in Moon Township / Coraopolis, PA, and requires cross‑functional collaboration to maintain inspection‑ready document control rooms and support batch record

Qualifications

• Bachelor’s degree or equivalent required or preferred.
• Knowledge of FDA regulations and electronic records guidelines is highly preferred.
• Experience with Veeva QualityDocs is a strong plus.
• Ability to maintain confidentiality and work with sensitive documents.
• Highly organized, detail oriented, and able to summarize information for cross‑functional teams.

Responsibilities

• Review, process and distribute controlled documents (SOPs, protocols, etc.) per format standards.
• Ensure accurate documentation and record keeping at all times.
• Maintain restricted access controls for documents and manage retention schedules.
• Support internal/external audits and regulatory inspections with GMP documentation.
• Coordinate batch record preparation, sampling plans, labels, and packaging activities.

Skills

Highly organized

Attention to detail

Excellent communication

Stakeholder management

Synthesis of information

Education

Bachelor's degree or equivalent

Tools

Veeva QualityDocs

Job description

Krystal Biotech, Inc is seeking a highly organized Quality Assurance Document Control Associate to support the implementation of quality and document control systems. The role will ensure compliance with internal procedures, cGMPs, and regulatory requirements within GMP manufacturing and QC labs.

This position is based at the Astra facility in Moon Township / Coraopolis, PA, and requires cross‑functional collaboration to maintain inspection‑ready document control rooms and support batch record