Quality Assurance Associate
Krystal Biotech
Summary
Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to support quality systems, GMP manufacturing processes and documentation practices. This role will support Krystal's Astra facility in Moon Township.
Job description
Job Description Summary
Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to support quality systems, GMP manufacturing processes and documentation practices. This role will support Krystal's Astra facility in Moon Township.
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.
Requirements
- Minimum of a Bachelor's Degree (Biology or related Life Science)
- 3+ years of relevant quality systems experience in the biotech or pharmaceutical industry
- 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
Company overview
Krystal Biotech, Inc. is a commercial-stage biotechnology company founded in 2016 and headquartered in Pittsburgh, Pennsylvania. The company specializes in the discovery, development, and commercialization of genetic medicines for diseases with high unmet medical needs. Krystal Biotech achieved a significant milestone in May 2023 when it received FDA approval for VYJUVEK®, the first-ever redosable gene therapy and the only medicine approved for treating dystrophic epidermolysis bullosa (DEB). This groundbreaking topical gene therapy gel delivers two copies of the COL7A1 gene directly to DEB wounds, addressing the fundamental disease-causing mechanism at the molecular level. The company leverages its proprietary herpes simplex virus type 1 (HSV-1) gene delivery platform to develop a robust pipeline of investigational genetic medicines across multiple therapeutic areas including respiratory diseases, oncology, dermatology, ophthalmology, and aesthetics. With state-of-the-art GMP manufacturing facilities in Pittsburgh and global operations extending to Switzerland, Germany, and Japan, Krystal Biotech has established itself as a global leader in redosable gene therapy technology, pioneering innovative approaches to treat rare genetic disorders.