About this role
Build Your Career at Krystal BiotechThanks for visiting our Career Page. Explore our current opportunities and apply to positions that match your experience, interests, and qualifications.About Krystal BiotechHeadquartered in Pittsburgh, Pennsylvania, Krystal Biotech has rapidly emerged as a global leader in gene therapy since 2016. The global approvals of the first-ever redosable gene therapy reflect our commitment to transforming groundbreaking science into life-changing treatments for patients with high unmet medical needs.Our approach brings together innovative science and technology, rapid and reliable manufacturing, and a patient-focused commercialization model as we continue to advance a robust pipeline of investigational genetic medicines.At Krystal, breakthrough innovation starts with exceptional people.
We foster a collaborative, inclusive, and fast-paced environment where curiosity is encouraged, diverse perspectives are valued, and every employee can make an impact.Whether you're in the lab, on the manufacturing floor, in the field, or supporting our business operations, you'll be part of a company led by its founders, where every role supports our mission to bring transformative therapies to patients around the world.Benefits That Support YouWe offer competitive compensation and a comprehensive benefits package designed to support our employees both at work and outside of it.Equity CompensationMedical and Prescription Drug CoverageDental and Vision InsuranceShort and Long-Term Disability Insurance401(k) With Company Match401(k) Annual Student Loan Match ProgramPaid HolidaysPaid Time OffFlexible Spending Accounts (Health Care & Dependent Care)Health Savings AccountEmployee Assistance Program & Benefits Concierge AppAD&D and Life InsuranceWellness Rewards ProgramQuality Assurance Document Control AssociateCoraopolis, PAFull TimeQuality AssuranceEntry 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 dynamic Quality Assurance Document Control Associate to support the implementation of our quality and document control systems. The primary focus of this role is to support the implementation of our quality and document control systems.
The Associate will work cross-functionally to ensure compliance with all internal procedures, cGMP’s, and regulatory requirements within the GMP manufacturing area and Quality Control laboratory. The Associate will perform administrative assistant duties for the Astra location.Responsibilities will include, but are not limited to, the following:General office organization and maintenanceKeeping the conference rooms, office and kitchen areas cleaned and stockedOffice supply ordering and tracking for the Astra locationCoordination of conference room bookingsGreet all visitors and ensure company sign-in policy is followed and/or answer the visitor arrival phone when applicableEnsure coverage is available for the front desk during all breaksAssist with shipping and receiving as requiredReview, process and distribute controlled documents, such as SOPs, protocols, and other technical documents while adhering to specific format standards and guidelinesEnsure accurate documentation and record keeping at all times.Continuously monitor that limited access restrictions are enforced for secure and controlleddocuments.Assist with data entry and administrative tasks to support access control for the Astra location as well as maintain the log for access loginsSupport controlled document life cycle/retention procedures.Manages records retention/archiving, while adhering to specific records retention schedulesSupports with internal and external audits and regulatory inspections, to include retrieval of GMP documentation.Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.Maintains an awareness of evolving industry standards for document generation and electronic document management.Maintains Document Control Room(s) in an inspection ready state. Ensures all paperwork is distributed, reconciled, archived, and filed in a timely manner.Other duties as assignedRequirements and Preferred Qualifications:Bachelor’s degree preferred, or equivalent combination of education and professional experience.Knowledge of FDA regulations and industry standard guidelines for electronic records, highly preferredAbility to maintain confidentiality and work with sensitive documents.Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking.Highly self-motivated, flexible, proactive, able to follow through in an ambiguous, fast-changingenvironment, and proven ability to meet deadlines under pressure.Demonstrated ability to prioritize and manage multiple projects simultaneously.Excellent interpersonal, collaboration and stakeholder management skillsExcellent communication skills (written/verbal)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.#LI-CF1ShareApplyApply for this positionRequiredFirst NameLast NameEmail AddressPhoneAddressResumeWe'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 LetterAre you willing to relocate?No answerYesNoWhat's your citizenship / employment eligibility?No answerI am a U.S.
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