Quality Assurance Associate

Krystal Biotech; Pittsburgh (Allegheny County); On-site; USD 70,000 - 95,000; Full time

Job summary

Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to support quality systems, GMP manufacturing processes and documentation practices at our headquarters in Pittsburgh's South Side.

The role involves collaborating with internal teams, producing high-quality documentation, and developing expertise on FDA regulations and audits to ensure ongoing compliance and continuous improvement of QA functions.

Qualifications

• Bachelor’s Degree in Biology or related Life Science with 3+ years of quality systems experience.
• Knowledge of GMP, GLP, and GCP.
• Experience with FDA audits preferred.
• Strong oral and written communication skills.

Responsibilities

• Work with internal teams to understand product and documentation requirements.
• Produce high-quality documentation meeting applicable standards.
• Develop expertise on FDA regulations and audit processes.
• Initiate and update GMP manufacturing related documentation.
• Provide oversight of daily QA functions including review/approval of records.
• Support updates to standard operating procedures and forms.
• Assist with QA efforts for site cGXP documentation.
• Ensure regulatory compliance and drive continuous QA improvements.

Skills

Quality Systems

GMP

FDA Audits

Documentation

ICH Guidelines

Education

Bachelor's degree in Biology

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.

Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.

Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.

Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.

Job Description Summary:

Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to support quality systems, GMP manufacturing processes and documentation practices at our headquarters in Pittsburgh's South Side.

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 affirmative action employer. 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.