Quality Assurance Document Control Specialist

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

Job summary

Krystal Biotech, Inc. is seeking a highly motivated QA Document Control Associate to support implementation of our quality and document control systems. The role ensures compliance with internal procedures, cGMPs, and regulatory requirements within GMP manufacturing and QC laboratories.

This position is based at the Astra facility in Moon Township / Coraopolis, PA, and involves cross-functional collaboration to maintain controlled documents, batch records, and audit readiness.

Qualifications

• Excellent interpersonal, collaboration and stakeholder management skills.
• Excellent communication skills (written/verbal).
• Highly organized and detail oriented with ability to synthesize information.
• Ability to prioritize and manage multiple projects simultaneously.
• Experience with confidential/sensitive documents.
• Adaptable to fast-changing environment and meet deadlines.

Responsibilities

• Review, process and distribute controlled documents (SOPs, protocols, technical documents).
• Ensure accurate documentation and record keeping at all times.
• Maintain restricted access controls for controlled documents.
• Support lifecycle/retention procedures for documents.
• Assist with batch record preparation and issuance activities.
• Coordinate document-related audits and regulatory inspections.»
• Maintain inspection-ready Document Control Room(s).
• Comply with all regulations, policies and safety rules.
• Support evolving document management standards.

Skills

Interpersonal skills

Communication skills

Organization / detail oriented

Project management

Confidentiality

Adaptability

Education

Bachelor’s degree preferred

Tools

Veeva QualityDocs

Job description

Krystal Biotech, Inc. is seeking a highly motivated QA Document Control Associate to support implementation of our quality and document control systems. The role ensures compliance with internal procedures, cGMPs, and regulatory requirements within GMP manufacturing and QC laboratories.

This position is based at the Astra facility in Moon Township / Coraopolis, PA, and involves cross-functional collaboration to maintain controlled documents, batch records, and audit readiness.