Biotech Quality Assurance Specialist (GMP/FDA)

Krystal Biotech, Inc.; Moon (VA); On-site; USD 75,000 - 110,000; Full time

Job summary

Krystal Biotech, Inc. is seeking a QA professional to support quality systems, GMP manufacturing processes, and documentation practices at our Astra facility in Moon Township.

The role emphasizes understanding product requirements, maintaining compliant documentation, and advancing regulatory readiness. You will develop expertise in FDA regulations and audit processes, initiate GMP documentation, and oversee daily QA activities including review of records.

Qualifications

• Minimum of a Bachelor’s Degree (Biology or related Life Science) with 3+ years of quality systems experience.
• Knowledge of GMP, GLP, and GCP.
• Experience with FDA audits is highly preferred.
• Strong knowledge of GMP and ICH requirements.

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 which include review and approval of records generated by manufacturing and quality control documents.
• Provide support for updates on standard operating procedures and associated forms.
• Assist with QA efforts for site cGXP documentation related to the operation of gene therapy manufacturing.
• Ensure compliance with regulatory agencies and oversee continuous improvement of company's QA and compliance functions.

Skills

Quality systems

Documentation management

Regulatory compliance

Cross-functional collaboration

Excellent communication

Education

Bachelor's degree in Biology or related Life Science

Job description

Krystal Biotech, Inc. is seeking a QA professional to support quality systems, GMP manufacturing processes, and documentation practices at our Astra facility in Moon Township.

The role emphasizes understanding product requirements, maintaining compliant documentation, and advancing regulatory readiness. You will develop expertise in FDA regulations and audit processes, initiate GMP documentation, and oversee daily QA activities including review of records.