Quality Assurance & Document Control Specialist

Krystal Biotech; United States; On-site; USD 60,000 - 80,000; Full time

Job summary

Krystal Biotech, Inc. seeks a highly organized Quality Assurance Document Control Associate to support GMP manufacturing and QC laboratories. You will manage controlled documents, maintain audit-ready records, and help ensure regulatory compliance across Astra location.

Responsibilities include coordinating document life cycle, supporting internal/external audits, and maintaining confidentiality while working cross-functionally with quality, manufacturing, and QA teams to uphold cGMP standards.

Qualifications

• Bachelor's degree or equivalent experience.
• Knowledge of FDA regulations and electronic records.
• Ability to maintain confidentiality with sensitive documents.
• Highly organized and detail oriented with strong synthesis.
• Proactive, flexible, able to meet deadlines under pressure.
• Excellent interpersonal and communication skills.

Responsibilities

• General office organization and maintenance.
• Review, process and distribute controlled documents, such as SOPs and protocols.
• Ensure documentation and record keeping are accurate and audit-ready.
• Maintain restricted access controls for controlled documents.
• Assist with data entry and access control logs at the Astra location.
• Support document lifecycle/retention procedures and archiving.
• Assist audits and regulatory inspections, retrieving GMP docs.
• Maintain document control rooms in inspection-ready state.
• Perform other duties as assigned.

Skills

Attention to detail

Organizational skills

Regulatory knowledge

Communication skills

Confidentiality

Education

Bachelor's degree or equivalent

Job description

Krystal Biotech, Inc. seeks a highly organized Quality Assurance Document Control Associate to support GMP manufacturing and QC laboratories. You will manage controlled documents, maintain audit-ready records, and help ensure regulatory compliance across Astra location.

Responsibilities include coordinating document life cycle, supporting internal/external audits, and maintaining confidentiality while working cross-functionally with quality, manufacturing, and QA teams to uphold cGMP standards.