GMP QC Lab Analyst for Gene Therapy Materials

Krystal Biotech, Inc.; Pittsburgh (Allegheny County); On-site; USD 65,000 - 95,000; Full time

Job summary

Krystal Biotech, Inc. in Pittsburgh, PA seeks a highly motivated Quality Control Analyst responsible for in‑house raw materials and product testing for both clinical and commercial drug products.

The role covers cGMP material inspection, testing, data review, and QC documentation. You will support document control, instrument qualification, and adherence to USP standards in a fast‑paced biopharma environment.

Qualifications

• Bachelor’s degree in life sciences or equivalent.
• Experience with pH, Osmo, Endotoxin, Appearance, customized media, cell culture, and FBS testing, preferred.
• Demonstrated experience in laboratory environment and ability to follow SOPs.
• 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.
• Proficient in Microsoft Word, Excel and PowerPoint.

Responsibilities

• Perform cGMP material inspection for all materials used for drug product manufacturing.
• Perform cGMP material testing for materials needed for manufacturing processes.
• Review analytical data for compliance and discuss non‑conformities with management.
• Participate in laboratory investigations and protocol/report development.
• Initiate and update quality control documentation (SOPs, monographs, test methods).
• Support Document Control and Record Retention activities.
• Implement USP Quality Standards and verify USP Methods.
• Maintain QC Lab equipment through qualification, calibration, and maintenance.
• Other duties as assigned.

Skills

MS Office

Attention to detail

Scientific writing

Education

Bachelor’s degree in life sciences

Job description

Krystal Biotech, Inc. in Pittsburgh, PA seeks a highly motivated Quality Control Analyst responsible for in‑house raw materials and product testing for both clinical and commercial drug products.

The role covers cGMP material inspection, testing, data review, and QC documentation. You will support document control, instrument qualification, and adherence to USP standards in a fast‑paced biopharma environment.