About the role
Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to support quality systems, GMP manufacturing processes and documentation practices at our headquarters in Pittsburgh's South Side.
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.