Quality Assurance Associate

Scorpion Therapeutics; Coraopolis (Allegheny County); On-site; USD 60,000 - 90,000; Full time

Job summary

Krystal Biotech in Pittsburgh is seeking a Quality Associate to support GMP manufacturing, focusing on quality systems, documentation, and regulatory compliance.

You will develop and review GMP documentation, oversee review and approval of manufacturing and QC records, support SOP updates, and ensure compliance with FDA and cGXP standards.

Qualifications

• Bachelor's degree in Biology or related Life Science.
• 1+ years in biotech/pharma quality systems.
• Knowledge of GMP/GLP/GCP preferred.
• Familiarity with FDA environments advantageous.

Responsibilities

• Develop and review GMP documentation.
• Oversee review and approval of manufacturing and QC records.
• Support SOP updates.
• Ensure compliance with FDA and cGXP standards.

Skills

Organization

Documentation

Communication

MS Office

Multitasking

Education

Bachelor's degree in Biology

Job description

Role

Quality Associate supporting GMP manufacturing at Krystal Biotech, focusing on quality systems, documentation, and regulatory compliance.

Responsibilities

• develop and review GMP documentation,
• oversee review and approval of manufacturing and QC records,
• support SOP updates,
• and ensure compliance with FDA and cGXP standards.

Requirements

• Bachelor's degree in Biology or related Life Science,
• 1+ years in biotech/pharma quality systems,
• knowledge of GMP/GLP/GCP preferred,
• familiarity with FDA environments advantageous.

Skills

• strong organizational, documentation, and communication abilities;
• proficient in MS Office;
• self-starter capable of multitasking in a fast-paced environment.

HighValue

• biotech/pharma quality systems,
• GMP manufacturing documentation,
• regulatory compliance,
• FDA environment experience.

Work Setup

Based in Pittsburgh headquarters, no travel specified.