Quality Control Analyst I - Gene Therapy QC Specialist

Krystal Biotech; Pittsburgh (Allegheny County); On-site; USD 60,000 - 85,000; Full time

Job summary

Krystal Biotech, Inc. is seeking a highly motivated Quality Control Analyst I to perform complex analytical testing for release of drug products for clinical and commercial use. You will support investigations, CAPA, and maintain QC lab readiness.

Responsibilities include finished product and stability testing, data review, and involvement in method validation and transfers. A life science degree and lab experience are required for this role in a fast-paced biotech environment.

Qualifications

• Bachelor’s degree in life science required.
• Experience with mammalian cell culture and common analytical assays.
• Strong written and verbal communication; detail oriented.

Responsibilities

• Perform finished product and stability testing and report results to management.
• Review data and notify management if data fails acceptance criteria.
• Support CAPA, deviation investigations, and quality systems.
• Participate in analytical method validation and method transfer.
• Maintain QC lab spaces and participate in audits.

Skills

Mammalian Cell Culture

Plaque Titer

ELISA

qPCR

Southern Blot

Western Blot

Environmental monitoring

Education

Bachelor’s degree in life science

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Krystal Biotech, Inc. is seeking a highly motivated Quality Control Analyst I to perform complex analytical testing for release of drug products for clinical and commercial use. You will support investigations, CAPA, and maintain QC lab readiness.

Responsibilities include finished product and stability testing, data review, and involvement in method validation and transfers. A life science degree and lab experience are required for this role in a fast-paced biotech environment.