Administrative / Office Assistant
Moon Township, PA
Full Time
Administrative
Entry Level
About 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 Administrative Assistant to support multiple departments at our Astra facility in Moon Township. The primary focus will be two-fold; in performing general administrative and front-desk duties, while also supporting Quality document control, in ensuring facility compliance with all internal procedures, cGMP’s, and regulatory guidelines.
Responsibilities will include, but are not limited to, the following:
- General office organization and maintenance.
- Keeping the conference rooms, office and kitchen areas cleaned and stocked.
- Office supply ordering and tracking.
- Coordination of conference room bookings.
- Greet all visitors and ensure company sign-in policy is followed and/or answer the visitor arrival phone when applicable.
- Ensure coverage is available for the front desk during all breaks.
- Assist with shipping and receiving as required.
- Issue controlled documents, such as batch records, labels and sampling plans, while adhering to specific format standards and guidelines
- Assist with data entry and administrative tasks to support access control for the Astra location as well as maintain the log for access logins.
- Support controlled document life cycle/retention procedures.
- Supports 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 assigned.
- Bachelor’s degree preferred, or equivalent combination of education and professional experience.
- Knowledge of FDA regulations and industry standard guidelines for electronic records, a plus.
- Ability 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-changing environment, and proven ability to meet deadlines under pressure.
- Demonstrated ability to prioritize and manage multiple projects simultaneously.
- Excellent interpersonal, collaboration and stakeholder management skills.
- Excellent communication skills (written/verbal).
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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