Quality Control Analyst I

Krystal Biotech•Pittsburgh, PA

About The Position

Krystal Biotech, Inc. is seeking a highly motivated Quality Control Analyst to perform complex analytical testing for the release of drug products for clinical and commercial use. The role performs finished-product and stability testing, reports and reviews QC results, supports laboratory and quality investigations, and contributes to analytical method validation or transfer. It also supports document control, record retention, material management, QC laboratory equipment and spaces, projects, and global audits.

Requirements

Bachelor’s degree in life science.
Experience with mammalian cell culture, plaque titer, ELISA, qPCR, Southern blot, and Western blot techniques.
Proficiency in Microsoft Word, Excel, and PowerPoint.
Self-starter who is highly motivated and able to address changing priorities.
Proactive approach and ability to work with a dynamic team.
Excellent scientific writing and written and oral communication skills.

Nice To Haves

Environmental monitoring experience.

Responsibilities

Perform finished-product testing and stability testing, and report QC results to management.
Review analytical data and notify management when results are outside prescribed acceptance criteria or specifications.
Support laboratory investigations, deviation investigations, CAPA, and CR as required by QC Management.
Initiate and complete clinical laboratory investigations as required.
Participate in analytical method validation and/or method transfer.
Support document control and record-retention activities.
Facilitate material purchasing, receipt, inventory, storage, and sampling.
Maintain QC laboratory equipment in accordance with equipment SOPs, working with QC Supervisors.
Participate in QC projects as needed and instructed.
Participate in global audits as required.
Maintain all QC laboratory spaces in an audit-ready state.
Perform other duties as assigned.