Quality Assurance Document Control Associate

Job overview

The Quality Assurance Document Control Associate position is onsite at the Astra facility in Moon Township/Coraopolis, PA. Compensation is not specified. The role supports Krystal Biotech’s quality and document control systems in its GMP manufacturing area and Quality Control laboratory. The associate manages controlled documents and records to support compliance with internal procedures, current good manufacturing practices, and regulatory requirements. The work helps keep documentation accurate, secure, retrievable, and inspection-ready throughout its lifecycle.

What you'll do

• Review, process, and distribute controlled documents
• maintain accurate records and access restrictions
• support document lifecycle and retention procedures
• archive records according to schedules
• assist with audits and regulatory inspections
• maintain document control rooms in inspection-ready condition
• coordinate batch record and sampling plan preparation and issuance, label printing, and commercial packaging activities.

What we're looking for

Skills & competencies

quality assurance

document control

gmp

controlled documents

sops

records retention

audit support

regulatory inspections

coraopolis pa

krystal biotech

veeva qualitydocs

fda regulations

Work arrangement

• Weekend coverage required

Why this role

Supports document control across GMP manufacturing and a Quality Control laboratory, including audit and inspection readiness.

About the employer

Krystal Biotech is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.