Quality Control Analyst I - Gene Therapy QC Specialist

Energy Jobline ZR; 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 I to perform complex analytical testing for the release of drug products used in clinical and commercial settings.

The role involves finished product testing, data review, supporting investigations, CAPA, and participation in method validation and transfer, with emphasis on maintaining audit-ready QC lab spaces and collaborating with a dynamic team in a GMP-driven environment.

Qualifications

• Bachelor’s degree in life science required.
• Experience in the following techniques: Mammalian Cell Culture, Plaque Titer, ELISA, qPCR, Southern Blot and Western Blot.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Environmental monitoring experience a plus but not required.
• A demonstrated self-starter who is highly motivated and able to address changing priorities.
• Ability to take a proactive approach on the job with the ability to work with a dynamic team.
• Excellent scientific writing, other written and oral communication skills are required.

Responsibilities

• Finished Product testing, stability testing, and reporting of QC results to management.
• Review analytical data and notify management if data falls outside acceptance criteria.
• Support laboratory investigations, deviation investigations, CAPA, and change requests as required by QC Management.
• 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 in accordance with SOPs and with QC Supervisors.
• Participate in QC projects and audits as required.
• Ensure QC Lab spaces remain audit-ready.

Skills

Mammalian Cell Culture

Plaque Titer

ELISA

qPCR

Southern Blot

Western Blot

Microsoft Word

Microsoft Excel

PowerPoint

Self-starter

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 the release of drug products used in clinical and commercial settings.

The role involves finished product testing, data review, supporting investigations, CAPA, and participation in method validation and transfer, with emphasis on maintaining audit-ready QC lab spaces and collaborating with a dynamic team in a GMP-driven environment.