Quality Assurance Associate

Scorpion Therapeutics; Pittsburgh (Allegheny County); On-site; USD 70,000 - 110,000; Full time

Job summary

Krystal Biotech in Pittsburgh, PA is seeking a Quality Associate to support GMP manufacturing and quality systems at its onsite headquarters.

You will develop and review GMP documentation, oversee daily QA activities, and ensure regulatory compliance, with a focus on cGXP and FDA expectations.

The ideal candidate holds a biology degree, 3+ years in biotech quality, and strong communication.

Qualifications

• Bachelor’s in Biology or related Life Science required.
• 3+ years in biotech/pharma quality systems.
• Strong knowledge of GMP, GLP, GCP, FDA audits, and ICH standards.
• Excellent communication and self-motivation.

Responsibilities

• Develop and review GMP documentation.
• Ensure regulatory compliance.
• Oversee daily QA functions including record review.
• Assist with SOP updates.

Skills

GMP knowledge

Quality systems

Documentation

Regulatory compliance

SOP updates

Biology background

Education

Bachelor’s in Biology or Life Science

Job description

Role

Quality Associate supporting GMP manufacturing and quality systems at Krystal Biotech's Pittsburgh headquarters.

Responsibilities

• Develop and review GMP documentation.
• Ensure regulatory compliance.
• Oversee daily QA functions including record review.
• Assist with SOP updates.

Requirements

• Bachelor’s in Biology or related Life Science.
• 3+ years in biotech/pharma quality systems.
• Strong knowledge of GMP, GLP, GCP, FDA audits, ICH standards.
• Self-motivated with excellent communication skills.

HighValue

• GMP manufacturing.
• cGXP documentation.
• FDA audit experience.
• Biotech/pharma industry.
• Quality oversight.

WorkSetup

Onsite in Pittsburgh; no travel specified.