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Quality Control Analyst II
2 months ago
Quality Control Analyst II
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, VYJUVEK™, 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 Quality Control Analyst who will perform complex analytical testing for the release of drug products for clinical and commercial use.
Primary Responsibilities:
- Finished Product testing, stability testing, reporting of the QC results to management
- Support laboratory investigations, deviation investigations, CAPA follow up and implementations, change control management including procedure and form revisions
- Participate in method transfer, validation/verification activities, as necessary
- Review analytical data for compliance with regulations, methods and other specifications or criteria
- Maintenance and calibration of QC Equipment
- Prepares applicable documents, forms, and records such as method forms, protocols, and work instructions following Good Document Practices
- Support internal and external Audits and Inspections, as required
Experience and Skills Desired:
- Bachelor’s degree in life science required.
- Experience in the following techniques: Mammalian Cell Culture, Plaque Titer, ELISA, qPCR, Southern Blot and Western Blot
- Proficient in Microsoft Word, Excel, and PowerPoint.
- Environmental monitoring experience a plus but not required.
- A demonstrated self-starter who is highly motivated and able to address changing priorities.
- Ability to take a proactive approach on the job with the ability to work with a dynamic team.
- Excellent scientific writing, other written and oral communication skills are required.
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.
