QC Analyst, Raw Materials - cGMP Drug Testing

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 responsible for in-house raw materials and product testing used in manufacturing clinical and commercial drug products. The role emphasizes cGMP compliance, data review, and rigorous documentation.

The candidate will ensure SOPs are followed, participate in investigations, and support equipment qualification and calibration to maintain quality standards across the QC lab.

Qualifications

• Bachelor’s degree in life sciences required.
• Experience with pH, Osmo, Endotoxin, Appearance testing preferred.
• Ability to follow SOPs and work in a GMP environment.

Responsibilities

• Perform cGMP material inspection and testing for drug product manufacturing.
• Review analytical data for regulatory compliance and collaborate when criteria aren’t met.
• Initiate and update QC documentation, including SOPs and test methods.
• Maintain QC lab equipment and coordinate calibration/maintenance.
• Support Document Control and Record Retention activities.

Skills

cGMP testing

SOP adherence

Data review

Documentation

Laboratory teamwork

Education

Bachelor’s degree in life sciences

Tools

Microsoft Office

Job description

Krystal Biotech, Inc. is seeking a highly motivated Quality Control Analyst responsible for in-house raw materials and product testing used in manufacturing clinical and commercial drug products. The role emphasizes cGMP compliance, data review, and rigorous documentation.

The candidate will ensure SOPs are followed, participate in investigations, and support equipment qualification and calibration to maintain quality standards across the QC lab.