QA Document Control Specialist – GMP & Compliance

krystalbiotech; Coraopolis (Allegheny County); On-site; USD 60,000 - 86,000; Full time

Job summary

Krystal Biotech, Inc. seeks a highly motivated Quality Assurance Document Control Associate to support the implementation of quality and document control systems within the GMP manufacturing area and Quality Control laboratory.

The role will work cross-functionally to ensure compliance with internal procedures and regulatory requirements at the Astra location. The Associate will perform administrative duties, manage controlled documents, support audits, and maintain an inspection-ready document

Qualifications

• Bachelor’s degree preferred, or equivalent combination of education and professional experience.
• Knowledge of FDA regulations and industry standard guidelines for electronic records, highly preferred
• Ability to maintain confidentiality and work with sensitive documents.
• Highly organized and detail oriented, capable of synthesizing information and meeting deadlines under pressure.

Responsibilities

• General office organization and maintenance.
• Coordinate conference room bookings and visitor sign‑in policy.
• Assist with shipping and receiving as required.
• Review, process and distribute controlled documents per SOPs and guidelines.
• Maintain accurate documentation and records with restricted access controls.
• Assist with internal and external audits and regulatory inspections.

Skills

FDA regulations

Document control

Attention to detail

Regulatory audits

Education

Bachelor’s degree or equivalent

Tools

Document management systems

Job description

Krystal Biotech, Inc. seeks a highly motivated Quality Assurance Document Control Associate to support the implementation of quality and document control systems within the GMP manufacturing area and Quality Control laboratory.

The role will work cross-functionally to ensure compliance with internal procedures and regulatory requirements at the Astra location. The Associate will perform administrative duties, manage controlled documents, support audits, and maintain an inspection-ready document