Quality Assurance Associate

Thanks for visiting our Career Page. Please review and apply to our positions which match your qualifications.Krystal Biotech, a Pittsburgh-based company founded in 2016, has quickly emerged as a global leader in gene therapy.

In May 2023, Krystal Bio received FDA approval for the first-ever redosable gene therapy, VYJUVEK™, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage their proprietary platform to develop new treatments throughout its clinical pipeline.

Additionally, the company has developed innovative commercial- and clinical-stage manufacturing processes, deployed across two state-of-the-art GMP facilities.BenefitsWe make every effort to provide essential and desirable benefits that make each employee's life that much easier. In addition to benefits listed below, we also offer competitive compensation that rewards you for your contributions toward achieving company goals.Benefits include:Equity / Stock OptionsMedical and Prescription Drug CoverageDental and Vision InsuranceShort and Long-Term Disability Insurance401(k) With Company MatchPaid HolidaysPaid Time OffFlexible Spending Accounts (Health Care & Dependent Care)Employee Assistance Program & Benefits Concierge AppAD&D and Life InsuranceWellness Rewards ProgramQuality Assurance AssociateMoon Township, PAFull TimeQuality AssuranceMid LevelShareAbout 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 tosupport quality systems, GMP manufacturing processes and documentation practices at our Astra manufacturing facility in Moon Township, PA.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 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.Krystal Biotech, Inc. is anEqual 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.ShareApplyApply for this positionRequired*First Name*Last Name*Email Address*Phone*AddressResume*We've received your resume. Clickhereto update it.Attach resumeorPaste resumeAttach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) orPaste resumePaste your resume here orAttach resume fileCover LetterWhat's your citizenship / employment eligibility?No answerI am a U.S.

Citizen/Permanent ResidentNon-citizen allowed to work for any employerNon-citizen allowed to work for current employerNon-citizen seeking work authorizationI am a Canadian Citizen/Permanent ResidentOtherDesired salaryEarliest start date?The following questions are entirely optional.To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law.

Your voluntary cooperation would be appreciated.Learn more.GenderDecline to answerFemaleMaleRace/EthnicityDecline to answerHispanic or LatinoWhite, not Hispanic or LatinoBlack or African-American, not Hispanic or LatinoAsian, not Hispanic or LatinoNative Hawaiian or Other Pacific Islander, not Hispanic or LatinoAmerican Indian or Alaskan Native, not Hispanic or LatinoTwo or More Races, not Hispanic or LatinoMENA (Middle Eastern and North African)Human Check*Submit Application