Quality Assurance Associate — Gene Therapy GMP

Krystal Biotech, Inc.; Moon (VA); On-site; USD 70,000 - 95,000; Full time

Job summary

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

You will work with internal teams to understand product requirements, develop compliant documentation, and maintain FDA-compliant records. The role requires knowledge of GMP/ICH guidelines and experience with regulatory audits, with a fast-paced environment and strong communication skills.

Qualifications

• Bachelor’s Degree in Biology or related Life Science with 3+ years quality systems experience.
• Knowledge of GMP, GLP, and GCP.
• Experience with FDA audits is highly preferred.
• Strong knowledge of GMP and ICH requirements.
• Self-starter who can work with minimal supervision.
• Ability to manage multiple tasks in a fast-paced environment.
• Excellent oral and written communication skills.

Responsibilities

• Collaborate with internal teams to understand product and documentation requirements.
• Produce high-quality documentation that meets standards.
• Develop expertise on FDA regulations and audit processes.
• Initiate and update GMP manufacturing documentation.
• Oversee daily QA functions including review/approval of records.
• Support updates to SOPs and related forms.
• Assist QA efforts for site cGXP documentation related to gene therapy manufacturing.
• Ensure compliance with regulatory agencies and drive continuous QA improvements.

Skills

Excellent communication

Self-starter

Multi-tasking

Education

Bachelor’s Degree in Biology or related Life Science

Job description

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

You will work with internal teams to understand product requirements, develop compliant documentation, and maintain FDA-compliant records. The role requires knowledge of GMP/ICH guidelines and experience with regulatory audits, with a fast-paced environment and strong communication skills.