Quality Assurance Associate Jobs

About Krystal Bio:

At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and delivery of transformative medicines for people with serious and life-threatening genetic diseases. Founded in 2016, the Company is the leader in redosable gene therapy with prominent clinical and pre-clinical stage programs for dystrophic epidermolysis bullosa, TGM1-deficient ARCI, Netherton Syndrome, Cystic Fibrosis, alpha-1 antitrypsin deficiency, and is advancing research to apply our technology to these and other diseases. The Company’s innovation is fueled by visionary leadership within an entrepreneurial organizational structure with a robust pipeline of investigational medicine.

Our US headquarters is in Pittsburgh, PA with other offices located in Boston, MA and in Zug, Switzerland. For more information about the Company’s platform, commitment to patients and pipeline, please visit and engage with us on and .

We have an exciting journey ahead and a tremendous opportunity for growth, and now is the time to make a meaningful impact on the lives of our patients!

Summary:

Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to support the implementation of our quality system, GMP manufacturing area, and Quality Control laboratory.

Primary Responsibilities:

• Provide support for updates on standard operating procedures and associated forms.
• Produce high-quality documentation that meets applicable standards and is appropriate for its intended use.
• Ensure compliance with regulatory agencies and oversee continuous improvement of company's QA and compliance functions.
• Initiate and update GMP manufacturing associated documentation, such as clearing procedures.
• Work with internal teams to obtain an understanding of the product and the documentation requirements.
• Provide oversight of daily QA functions which include review and approval of records generated by manufacturing and quality control documents.
• Assist with QA efforts for site cGXP documentation related to the operation of gene therapy manufacturing.

Requirements & Desired Competencies:

• Background that includes knowledge/experience in GMP, GLP, and GCP.
• Strong knowledge of GMP and ICH requirements.
• Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities appropriately.
• 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.
• Must be a self-starter and capable of working with minimal oversight.
• 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.

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