QC Analyst I: Release Testing & Investigations

Krystal Biotech, Inc.; Pittsburgh (Allegheny County); On-site; USD 65,000 - 90,000; Full time

Job summary

Krystal Biotech, Inc is seeking a highly motivated Quality Control Analyst who will perform complex analytical testing for the release of drug products for clinical and commercial use. The role involves finished product testing, stability studies, and reporting QC results to management, plus supporting investigations, deviations, CAPA, and change requests as required by QC leadership.

You will participate in method validation or transfer, maintain documentation and records, support material

Qualifications

• Bachelor’s degree in life science required.
• Experience with mammalian cell culture and analytical assays.
• Proficient in Word, Excel, PowerPoint.
• Self-starter with ability to adapt to priorities.
• Strong scientific writing and communication skills.

Responsibilities

• Perform finished product testing and report QC results to management.
• Review analytical data and flag out-of-criteria data.
• Support laboratory investigations, CAPA, and change requests as required by QC leadership.
• Initiate and complete clinical laboratory investigations as needed.
• Assist in method validation or transfer.
• Maintain documentation and records, including record retention.
• Support material management and equipment upkeep in the QC lab.
• Participate in global audits and ensure an audit-ready lab space.

Skills

Mammalian Cell Culture

Plaque Titer

ELISA

qPCR

Southern Blot

Western Blot

Microsoft Word

Microsoft Excel

PowerPoint

Scientific writing

Communication skills

Self-starter

Education

Bachelor’s degree in life science

Tools

Microsoft Office Suite

Job description

Krystal Biotech, Inc is seeking a highly motivated Quality Control Analyst who will perform complex analytical testing for the release of drug products for clinical and commercial use. The role involves finished product testing, stability studies, and reporting QC results to management, plus supporting investigations, deviations, CAPA, and change requests as required by QC leadership.

You will participate in method validation or transfer, maintain documentation and records, support material