Quality Assurance Document Control Associate

Scorpion Therapeutics; Coraopolis (Allegheny County); On-site; USD 70,000 - 90,000; Full time

Job summary

Krystal Biotech is seeking a Quality Assurance Document Control Associate to support the implementation of document control systems within GMP manufacturing and QC lab. Responsibilities include reviewing, processing, and distributing controlled documents (SOPs, protocols), managing document lifecycle, and ensuring compliance with FDA regulations.

This role supports audits and inspections and coordinates batch activities.

Qualifications

• Bachelor's degree or equivalent experience preferred.
• Knowledge of FDA regulations and electronic record systems (Veeva QualityDocs preferred).
• Highly organized, detail-oriented, able to handle sensitive documents.
• Strong communication and stakeholder management skills.

Responsibilities

• Review, process, and distribute controlled documents (SOPs, protocols).
• Manage document lifecycle and ensure compliance with cGMP and regulatory standards.
• Maintain records retention and assist audits and inspections.
• Coordinate batch activities.

Skills

Attention to detail

Stakeholder management

Communication

Education

Bachelor's degree or equivalent experience

Tools

Veeva QualityDocs

Job description

Role

Quality Assurance Document Control Associate supporting implementation of document control systems within GMP manufacturing and QC lab at Krystal Biotech.

Responsibilities

Responsibilities: review, process, and distribute controlled documents (SOPs, protocols), manage document lifecycle, ensure compliance with cGMP and regulatory standards, maintain records retention, support audits and inspections, and coordinate batch activities.

Requirements

Requirements: Bachelor's degree preferred or equivalent experience; knowledge of FDA regulations and electronic record systems (Veeva QualityDocs preferred); highly organized, detail-oriented, able to handle sensitive documents, with strong communication and stakeholder management skills.

High-Value

High-Value: GMP manufacturing, quality systems, document control, FDA compliance, biotech/pharma regulations, support for investigational or commercial gene therapy products, based in Moon Township, PA.