Biotech Quality Assurance Associate — GMP & Regulatory Ready

Krystal Biotech, Inc.; Pittsburgh (Allegheny County); 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, GMP manufacturing processes and documentation practices at our Pittsburgh headquarters.

Join a fast-paced biotech environment focused on gene therapy; you will produce compliant documentation, assist with FDA audits, and help maintain cGXP records. Bachelor's in Biology with 3+ years QA experience preferred; strong communication and ability to work with minimal oversight.

Qualifications

• Bachelor's Degree (Biology or Life Science) with 3+ years quality systems experience.
• Knowledge of GMP, GLP, and GCP.
• Experience with FDA audits preferred.
• Strong written and oral communication.

Responsibilities

• Support quality systems and GMP manufacturing documentation.
• Produce high-quality documentation meeting standards.
• Develop expertise on FDA regulations and audit processes.
• Initiate and update GMP manufacturing documentation.
• Provide oversight of QA functions including review/approval.
• Support updates to SOPs and forms.
• Assist with cGXP documentation for gene therapy manufacturing.
• Ensure regulatory compliance and drive QA improvements.

Skills

GMP knowledge

FDA audit experience

Quality systems experience

Strong 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 practices at our Pittsburgh headquarters.

Join a fast-paced biotech environment focused on gene therapy; you will produce compliant documentation, assist with FDA audits, and help maintain cGXP records. Bachelor's in Biology with 3+ years QA experience preferred; strong communication and ability to work with minimal oversight.