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Quality Assurance Associate

3 months ago

Dallas City, Illinois, United States Krystal Biotech, Inc. Full time
Quality Assurance Associate

About Krystal Bio:
At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and commercialization of gene delivery medicines for patients with serious and life-threatening genetic diseases. Founded in 2016, Krystal is a leader in gene therapy. Krystal received U.S. FDA approval for the first-ever redosable gene therapy treatment, VYJUVEKTM, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage our proprietary platform to develop new treatments across a robust clinical pipeline. Located near Krystal's headquarters are two state-of-the-art GMP facilities.

Krystal Biotech is based in Pittsburgh, PA which is home to our two state-of-the-art GMP facilities. Additional offices are situated in Boston, MA and in Zug, Switzerland.

Join us on our journey to implement our mission to identify, develop and deliver genetic medicines to patents

Job Description Summary:

Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to support quality systems, GMP manacturing processes and documentation practices through the expansion of our new, state-of-the art GMP 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.
  • 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.
  • 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 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.