Quality Assurance Document Control Associate
Full-time
Krystal Biotech
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. Position 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. This position is based out of our Astra facility in Moon Township / Coraopolis, PA. Primary Responsibilities:
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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. This position is based out of our Astra facility in Moon Township / Coraopolis, PA. Primary Responsibilities:
- Review, process and distribute controlled documents, such as SOPs, protocols, and other technical documents while adhering to specific format standards and guidelines
- Ensure accurate documentation and record keeping at all times.
- Continuously monitor that limited access restrictions are enforced for secure and controlled documents.
- Support controlled document life cycle/retention procedures.
- Manages records retention/archiving, while adhering to specific records retention schedules
- 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.
- Coordinate and maintain batch associated activities such as batch record preparation and issuance, sampling plan preparation and issuance, label printing and commercial packaging.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- 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, highly preferred.
- Experience with Veeva QualityDocs preferred.
- 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.
- 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).
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Vacancy posted 3 days ago
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