Job Description

Krystal Biotech Inc. in Pittsburgh, PA is looking for one quality assurance associate to join our team. Our ideal candidate is self-driven, ambitious, and reliable.

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.

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.

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:

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 is highly 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.

Benefits:

Highly competitive salaries

Company matched 401(k) program

Comprehensive medical, dental and vision coverage

Five months fully paid parental leave for new parents

Flexible time off and all U.S. federal holidays

Robust employee assistance program (EAP), including access to mental health services for employees and their families

We are looking forward to hearing from you.

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