Quality Assurance Associate, Gene Therapy GMP

Krystal Biotech; Moon Township (Allegheny County); On-site; USD 60,000 - 80,000; Full time

Job summary

Krystal Biotech is hiring a Quality Associate to support quality systems and GMP manufacturing processes at their facility in Moon Township, PA. The role involves producing documentation, ensuring compliance with FDA regulations, and supporting QA efforts.

Ideal candidates should have a Bachelor’s degree in Biology or a related field, at least 3 years of relevant experience, and strong knowledge of GMP and ICH requirements. Excellent communication skills are essential for collaborating effectively with internal teams.

Qualifications

• Minimum of 3+ years of relevant quality systems experience in the biotech/pharmaceutical industry.
• Experience with FDA audits is highly preferred.
• Must be a self-starter and capable of working with minimal oversight.

Responsibilities

• Produce high-quality documentation meeting applicable standards.
• Initiate and update GMP manufacturing associated documentation.
• Ensure compliance with regulatory agencies.

Skills

GMP knowledge

Quality systems experience

FDA regulations

Excellent communication skills

Education

Bachelor’s Degree in Biology or related Life Science

Job description

Krystal Biotech is hiring a Quality Associate to support quality systems and GMP manufacturing processes at their facility in Moon Township, PA. The role involves producing documentation, ensuring compliance with FDA regulations, and supporting QA efforts.

Ideal candidates should have a Bachelor’s degree in Biology or a related field, at least 3 years of relevant experience, and strong knowledge of GMP and ICH requirements. Excellent communication skills are essential for collaborating effectively with internal teams.