Quality Assurance Associate

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

About Krystal Bio

At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.

Job Description Summary

support quality systems, GMP manufacturing processes and documentation practices. This role will support Krystal's Astra facility in Moon Township.

Primary 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.

Requirements & Desired Competencies

• Minimum of a Bachelor’s Degree (Biology or related Life Science) with 3+ years of relevant quality systems experience in the biotech or pharmaceutical industry.
• Background that includes knowledge/experience in GMP, GLP, and GCP.
• Experience with FDA audits ishighly preferred.
• Strong knowledge of GMP and ICH requirements.
• Must be a self-starter and capable of working with minimal oversight.
• Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities appropriately.
• Excellent oral and written communication skills.

Krystal Biotech, Inc. is an Equal Employment Opportunity and Aff… Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.