Quality Control Analyst I: Gene Therapy Product Testing

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

Job summary

Krystal Biotech in Pittsburgh is seeking a highly motivated Quality Control Analyst to perform complex analytical testing for the release of drug products for clinical and commercial use. You will review data, support investigations and CAPA, participate in method validation and ensure audit-ready QC labs; the role requires a life science degree and experience with ELISA, qPCR, and blot techniques.

Join a leading gene therapy company applying rigorous science in a fast-paced, collaborative

Qualifications

• Bachelor’s degree in life science required.
• Experience with mammalian cell culture, ELISA, qPCR, and blotting techniques.
• Proficiency in Word, Excel, and PowerPoint.
• Environmental monitoring experience is a plus but not required.

Responsibilities

• Finished Product testing, stability testing, and reporting QC results to management.
• Review analytical data and notify management if data is outside acceptance criteria.
• Support laboratory investigations, deviation investigations, CAPA, and change requests.
• Initiate and complete clinical laboratory investigations as required.
• Participate in analytical method validation and/or method transfer.
• Support activities for Document Control and Record Retention.
• Facilitate material management through purchasing, receipt, inventory, storage, and sampling.
• Maintain QC Lab equipment per SOPs with QC Supervisors.
• Participate in QC projects and global audits as required.
• Keep QC lab spaces audit-ready and organized.
• Other duties as assigned by QC management.

Skills

Mammalian cell culture

ELISA

qPCR

Western blot

Southern blot

Plaque titer

Microsoft Word

Microsoft Excel

PowerPoint

Environmental monitoring

Education

Bachelor’s degree in life science

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Krystal Biotech in Pittsburgh is seeking a highly motivated Quality Control Analyst to perform complex analytical testing for the release of drug products for clinical and commercial use. You will review data, support investigations and CAPA, participate in method validation and ensure audit-ready QC labs; the role requires a life science degree and experience with ELISA, qPCR, and blot techniques.

Join a leading gene therapy company applying rigorous science in a fast-paced, collaborative