Quality Assurance Associate

Krystal Biotech • Pittsburgh, PA

1d • Onsite

About The Position

Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to support quality systems, GMP manufacturing processes, and documentation practices. This onsite role may support either or both of the company’s facilities in South Side and Moon Township.

The position supports quality assurance and compliance functions for gene therapy manufacturing, including reviewing and approving manufacturing and quality control records, maintaining GMP documentation, supporting procedures and forms, and ensuring compliance with regulatory requirements. The role also involves learning FDA regulations and audit processes and contributing to continuous improvement of the company’s QA and compliance functions.

Requirements

• Bachelor’s degree in Biology or a related life science.
• At least 3 years of relevant quality systems experience in the biotech or pharmaceutical industry.
• Knowledge or experience in GMP, GLP, and GCP.
• Strong knowledge of GMP and ICH requirements.
• Ability to work independently with minimal oversight.
• Ability to handle multiple roles and prioritize activities in a fast-paced, changing environment.
• Excellent oral and written communication skills.

Nice To Haves

• Experience with FDA audits is highly preferred.

Responsibilities

• Work with internal teams to understand products and documentation requirements.
• Produce high-quality documentation that meets applicable standards and is appropriate for its intended use.
• Develop expertise in FDA regulations and audit processes.
• Initiate and update GMP manufacturing-associated documentation, such as clearing procedures.
• Provide oversight of daily QA functions, including reviewing and approving records generated by manufacturing and quality control documents.
• Support updates to standard operating procedures and associated forms.
• Assist with QA efforts for site cGXP documentation related to gene therapy manufacturing operations.
• Ensure compliance with regulatory agencies and oversee continuous improvement of the company’s QA and compliance functions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level