Quality Assurance Associate

Krystal Biotech; Pittsburgh (Allegheny County); On-site; USD 65,000 - 90,000; Full time

Job summary

Krystal Biotech, Inc. is seeking a highly motivated Quality Associate to support quality systems, GMP manufacturing processes, and documentation practices at our on-site facilities in the Pittsburgh area (South Side or Moon Township).

This role requires a Bachelor’s in Life Science and 3+ years in biotech quality, with GMP/GLP/GCP expertise and FDA audit experience. You will develop, review, and maintain records, and help drive regulatory compliance and continuous improvement across QA functions.

Qualifications

• Minimum of a Bachelor’s Degree (Biology or related Life Science) with 3+ years of quality systems experience.
• Background that includes knowledge/experience in GMP, GLP, and GCP.
• Experience with FDA audits is highly preferred.

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 including review and approval of records.

Skills

GMP knowledge

ICH guidelines

FDA audits

GCP/GLP

Documentation skills

Strong communication

Education

Bachelor’s Degree in Biology or Life Science

Tools

LIMS

MS Office

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. This onsite role will potentially support either or both facilities (South Side / 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 Affimative Action Employers. 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.