Quality Assurance Associate - GMP & Gene Therapy

Krystal Biotech; Pittsburgh (Allegheny County); On-site; USD 65,000 - 90,000; 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 on-site facilities in the Pittsburgh area (South Side or Moon Township).

This role requires a Bachelor’s in Life Science and 3+ years in biotech quality, with GMP/GLP/GCP expertise and FDA audit experience. You will develop, review, and maintain records, and help drive regulatory compliance and continuous improvement across QA functions.

Qualifications

• Minimum of a Bachelor’s Degree (Biology or related Life Science) with 3+ years of quality systems experience.
• Background that includes knowledge/experience in GMP, GLP, and GCP.
• Experience with FDA audits is highly preferred.

Responsibilities

• Work with internal teams to obtain an understanding of the product and the documentation requirements.
• Produce high-quality documentation that meets applicable standards and is appropriate for its intended use.
• Develop expertise on FDA regulations and audit processes.
• Initiate and update GMP manufacturing associated documentation, such as clearing procedures.
• Provide oversight of daily QA functions including review and approval of records.

Skills

GMP knowledge

ICH guidelines

FDA audits

GCP/GLP

Documentation skills

Strong communication

Education

Bachelor’s Degree in Biology or Life Science

Tools

LIMS

MS Office

Job description

Krystal Biotech, Inc. is seeking a highly motivated Quality Associate to support quality systems, GMP manufacturing processes, and documentation practices at our on-site facilities in the Pittsburgh area (South Side or Moon Township).

This role requires a Bachelor’s in Life Science and 3+ years in biotech quality, with GMP/GLP/GCP expertise and FDA audit experience. You will develop, review, and maintain records, and help drive regulatory compliance and continuous improvement across QA functions.