Biotech QA Specialist — GMP Compliance & Documentation

Krystal Biotech; Moon Township (Allegheny County); On-site; USD 70,000 - 110,000; Full time

Job summary

Krystal Biotech, Inc. is seeking a highly motivated Quality Associate to support quality systems, GMP manufacturing processes and documentation at our Astra facility in Moon Township.

This role will develop expertise on FDA regulations and audits, initiate and update GMP documentation, review manufacturing records, and drive QA improvements across the site. You will collaborate with cross-functional teams and ensure regulatory compliance.

Qualifications

• Minimum bachelor’s degree in biology or life science.
• 3+ years of quality systems experience in biotech/pharma.
• GMP/GLP/GCP knowledge.
• Experience with FDA audits is preferred.
• Strong written and verbal communication.

Responsibilities

• Prepare and update GMP manufacturing related documentation.
• Review records generated by manufacturing and QC.
• Support SOP updates and related forms.
• Ensure regulatory compliance and drive QA improvement.
• Collaborate with internal teams to understand product and documentation needs.
• Develop expertise on FDA regulations and audit processes.
• Assist with site cGXP documentation for gene therapy operations.

Skills

GMP knowledge

ICH knowledge

FDA audits experience

Documentation & quality systems

Excellent communication

Education

Bachelor’s Degree in Biology or Life Science

Job description

Krystal Biotech, Inc. is seeking a highly motivated Quality Associate to support quality systems, GMP manufacturing processes and documentation at our Astra facility in Moon Township.

This role will develop expertise on FDA regulations and audits, initiate and update GMP documentation, review manufacturing records, and drive QA improvements across the site. You will collaborate with cross-functional teams and ensure regulatory compliance.